Patent Exclusivity Research Articles

Use and Cost Patterns of Antihypertensive Medications in the United States From 1996 to 2021.

Antihypertensive medication use patterns have likely been influenced by changing costs and accessibility over the past 3 decades. This study examines the relationships between patent exclusivity loss, medication costs, and national health policies on antihypertensive medication use. Using 1996 to 2021 Medical Expenditure Panel Survey data of US adults with hypertension taking at least 1 antihypertensive medication, we conducted a cross-sectional analysis. We explored the associations between patent exclusivity loss, per-pill costs, and Medicare Part D enactment on medication use over time, focusing on the most commonly used medications (lisinopril, amlodipine, losartan, hydrochlorothiazide, and metoprolol). The unweighted sample comprised 50 095 US adults (mean age, 62 years; 53% female). The survey-weighted number of adults taking antihypertensive medications increased from 22 million (95% CIs, 20-23 million) to 55 million (95% CI, 51-60 million) between 1996 and 2021. Loss of patent exclusivity led to increased medication fills, notably for lisinopril, amlodipine, and losartan, which all exhibited within-class dominance. However, per-pill cost decreases coinciding with Medicare Part D did not increase the number of individuals treated or the use of specific antihypertensive medications or classes. The increase in antihypertensive medication use over the past decades highlights the significant impact of loss of patent exclusivity on the uptake in the use of specific medications. These findings underscore the complexity of factors influencing medication use, beyond cost reductions alone, and suggest that policies need to consider multiple facets to effectively improve antihypertensive medication accessibility and utilization.

How promotion mix helps sustain brand sales during market transitions: insights from the pharmaceutical industry

Purpose Pharmaceutical marketers use detailing, sampling and direct-to-consumer advertising (DTCA) to promote a branded prescription drug (brand drug) to health-care professionals and consumers. These promotion mix elements help raise brand awareness, increase prescription likelihood and guard a product market against competing brand drugs. However, the extent to which these elements remain effective when a brand drug goes off patent and its marketing exclusivity expires, allowing low-price generics to enter the market, remains unclear. This study aims to explore the effectiveness of promotion mix elements before and after the market entry of a generic drug. Design/methodology/approach The authors collected and analyzed a panel data set of 41 brand drugs from 7 therapeutic classes between 2007 and 2014 (3,201 observations) using the two-stage control function approach to address potential endogeneity. Findings The effectiveness of promotion mix elements changes significantly, but not in a universally uniform way, during a market transition. Detailing and DTCA are increasingly effective after a brand drug’s generics enter the market. In contrast, sampling is more effective before the market transition. The positive effects of sampling on brand sales are stronger when the price of a brand drug is higher than the average price of its competing brands. Sampling also helps amplify the positive influences of detailing and DTCA on brand sales. Research limitations/implications This study shows that pharmaceutical promotion is not equally effective in the brand drug market with/without generic competitors. Detailing and DTCA are increasingly effective when generic competition intensifies. In contrast, the distribution of free drug samples is less effective after more generic drugs enter the market. Practical implications Incumbent brands’ promotion expenditures often drop dramatically when the expiration of their patents is near, a practice that likely continues after generics enter the market. Taking into consideration these industry norms and their findings, the authors suggest that promotional decisions during a market transition should not overly focus on cutting promotional expenditures across the board. Since a firm’s promotional expenditure tends to be expensive, factoring in information on the effectiveness of each promotion mix element helps marketers make well-informed strategic decisions on resource allocation during the transition from a market without generics to a market with generics. Originality/value Previous studies do not explicitly account for structural changes in the brand drug market over time. However, the expiration of patent and marketing exclusivity marks a transitional period in which a brand drug eventually competes with its generic counterparts. Given the criticality of such structural change, the authors examine brand drugs’ promotion effectiveness in the presence of their generic counterparts.

Investigating market trends and access implications for adalimumab following the loss of patent exclusivity: Lessons learned from biosimilar uptake in the U.S. biologic market

Investigating market trends and access implications for adalimumab following the loss of patent exclusivity: Lessons learned from biosimilar uptake in the U.S. biologic market

Compulsory Licensing During Pandemic Times: Possible Lessons From the Efavirenz Case

During the Covid-19 pandemic, partnerships between Brazilian laboratories and international companies were impor tant for the local production of the vaccine, due to the necessity to find an effective measure to preserve public health. However, it is necessary to investigate these partnerships beyond their benefits in order to understand their implications. Compulsory licensing consists of an exception to the transfer of technology contracts to guarantee the Brazilian’s population access to the vaccine and possible new drugs developed against Covid-19. Compulsory licensing has already been implemented in Brazil. In 2007, it was used by the federal government to solve the problem of access to efavirenz, an antiretroviral needed in the treatment of HIV/AIDS. Considering the similarities between the epidemics, this article aimed to answer, through empirical analysis, what the efavirenz case reveals about the legaleconomic process of patent exclusivity and the use of compulsory licensing during times of pandemic crises, such as the one of Covid-19. Based on the analysis of the bureaucratic process applied to the Efavirenz case, it was possible to infer that the compulsory license should have been executed by the Brazilian government to guarantee access to medical products during national emergencies.

Why Does the Inflation Reduction Act Exclude Expensive Cancer Treatments in Price Negotiations?

The Inflation Reduction Act (IRA) includes provisions for price negotiations of certain high-spending drugs in Medicare Parts B and D. This provision received considerable attention from those interested in the costs of cancer care since Medicare covers most patients with cancer and many cancer drugs are expensive. We simulate how many cancer drugs may be eligible for IRA price negotiations and examine the reasons that many are likely to be excluded from negotiation. This study uses 2021 Medicare Fee-for-Service Part B and Part D prescription drugs expenditure data. Cancer drugs were identified using the SEER Program list of cancer medications. Our measures included total spending, beneficiary users, and spending-per-beneficiary for all cancer drugs covered under Medicare. Each drug was evaluated for eligibility on the basis of IRA negotiation provisions, including estimated loss of patent exclusivity, current competitors, and orphan drug designation. We found that very few cancer drugs will meet the IRA eligibility thresholds to be included in negotiations. We estimate that only 2.2% of beneficiaries with cancer will see lower costs because of the IRA negotiations. The main reason for this is that although novel cancer drug treatments are priced high, they generally treat relatively few beneficiaries and thus do not meet negotiation eligibility criteria, which are primarily based on a ranking of total spending. The IRA negotiation provisions will have limited impact on cancer drug prices and will likely leave most patients with cancer exposed to high drug costs.

Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019.

Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity. We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (NDA)-e.g., a vial and pen-were considered as separate products for the purposes of analysis. We recorded all patents and regulatory exclusivities listed in the Orange Book on each product and used Google Patents to extract the timing of patent application and whether patents were obtained on delivery devices or others aspects of the product. The primary outcome was the duration of expected protection, which was determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity (whichever occurred later). We performed a secondary analysis that considered overall protection on insulin lines-defined as groups of products approved under the same NDA with the same active ingredients manufactured by the same company. We also examined competition from follow-on insulin products-defined as products approved with the same active ingredients as originators but manufactured by different companies (approved via a specific drug approval pathway under section 505(b)(2) of the Food, Drug, and Cosmetic Act). During the study period, the FDA approved 56 individual products across 25 different insulin lines and 5 follow-ons across 3 different insulin lines. Thirty-three (59%) of the 56 products were drug-device combinations. Manufacturers of 9 products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection (by a median of 6 years). Approximately 63% of all patents on drug-device combinations approved during the study period were related to delivery devices. The median duration of expected protection on insulin products was 16.0 years, and the median protection on insulin lines was 17.6 years. An important limitation of our analysis is that manufacturers may continue to add patents on existing insulin products while competitors may challenge patents; therefore, periods of protection may change over time. Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs.

An In-Depth Financial Analysis of Pfizer Inc

This paper analyzes the economic performance of Pfizer, a leading biopharmaceutical company, from a business perspective. Pfizer has a long history of innovation and significant contributions to the global healthcare industry for over 170 years. Despite facing challenges such as the loss of patent exclusivity for some key products and the impact of the COVID-19 pandemic on its business operations, Pfizer has continued to perform well financially. Using Pfizer's most recent annual report, this essay examines the company's financial performance in 2022, where it had total revenues of $100.3 billion, an increase of 30% from the previous year. The company's net income was $31.4 billion, a significant increase from $22 billion in 2021. The report also indicates that Pfizer's financial performance was driven by growth in key therapeutic areas, including oncology, inflammation and immunology, and rare diseases. Additionally, the company's COVID-19 vaccine, which received emergency use authorization from regulatory agencies around the world, played a significant role in Pfizer's financial performance. Looking ahead, Pfizer has a strong pipeline of potential new medicines in the fields of oncology, immunology, neurology, and other therapeutic areas. The company's commitment to innovation is evident in its investments in research and development, which have enabled it to bring many important new treatments to market. Despite the challenges faced by the industry and the world due to the COVID-19 pandemic, Pfizer's financial performance has remained strong, and the company is well-positioned to continue its success in the future.

DOP55 The increasing burden of direct and indirect costs of IBD

Abstract Background The cost of care for inflammatory bowel disease (IBD) has nearly doubled over the last two decades. With an increasing number of patients and evolving treatment paradigms utilizing costly but efficacious biologic agents earlier and more often, the cost burden is only expected to worsen. Furthermore, IBD carries significant indirect costs to lost productivity of patients and their caregivers and out-of-pocket healthcare expenses borne directly by patients. Methods This talk will explore the current landscape and drivers of IBD direct costs and indirect costs as well as discuss challenges in assessing and comparing such data across countries Results Direct costs of IBD management have shifted substantially in recent years, primarily due to the emergence and penetrance of biologic therapy into clinical practice. Despite the increased use of biologic agents in IBD treatment, the expenditure on hospitalization and surgery has had a relatively small impact on reductions in cost, and the mean per capita costs spent on biologics in recent years is higher than what was saved on hospitalization per capita. In fact, direct health care costs associated with IBD treatment have dramatically increased over the last decade. New biologics and small molecules are also expected to be approved in the coming years, which is only likely to further increase the economic burden of IBD. These drivers of increasing costs may be offset by the recent loss of patent exclusivity for infliximab and adalimumab in much of the Western world, which has allowed for increased competition in the form of biosimilar agents and a reduction in prices. The greatest burden of indirect costs in this population relates to absenteeism and presenteeism among working individuals and premature retirement. However, costs related to reduced professional development and personal achievement due to illness—as well as caregiver costs—are largely unknown. Conclusion IBD is an expensive chronic disease with payments only expected to rise. Treating CD remains more expensive than treating UC and biologics escalate treatment costs and these are not offset by possible reductions of hospitalization and other costs. Direct costs differ substantially between countries and health care systems. Indirect cost constitute a significant burden on society

과도한 의약품 시장독점 방지를 위한 연장된 특허권 존속기간의 비교

The extended patent term or exclusivity period from pharmaceuticals’ approval date is limited to 14 years in the US or 15 years in the EU. However there are no such restrictions in Korea, so the market exclusivity can be excessively extended. Therefore, the status of extension of patent term in Korea was analyzed and the patent term from the product’s approval date in Korea, the US, Japan, the UK, France, and Germany were compared. For that, the following information from NEDRUG or KIPRIS were collected and analyzed: the filing date of the patent, whether the patent term has been extended, the expiration date of the patent term, approval date, the products’ name, and representative claims. Alecensa, Xalkori, Biktarvy, and Champix were selected for the comparison. Among 597 patents in Korea, 90.1% (538) were extended and 17.1% (102) of patents exceeded 14 years from the approval date. There were 81 and 60 products that have patents whose term exceeds 14 and 15 years from the approval date, respectively. In the comparative cases of 4 products, the patent term from products’ approval date in Korea is longer than 14 or 15 years, whereas the US, the UK, France, and Germany comply with the regulated limitation. The excessive patent protection delays the market entry of lower-cost generics and leads to an increase in financial burden on healthcare cost. To address such problems, a proper limitation on the extension of the patent term from the product’s approval date needs to be established.

Estimating the impact of biosimilar entry on prices and expenditures in rheumatoid arthritis: a case study of targeted immune modulators

Objective To model changes in prices, utilization, and expenditures of targeted immune modulators (TIMs) for rheumatoid arthritis, accounting for biosimilar entry. Methods Using IQVIA National Sales Perspective data between 2013 and 2019, we examined sales and expenditures of biologics and non-biological complex molecules, 20 quarters before and after patent exclusivity milestones. We estimated the impact of a molecule’s exclusivity milestones and biosimilar entry on prices, using a regression discontinuity design (RDD). We then combined the RDD estimate with historical trends to assess the impact of adalimumab’s exclusivity milestones on future TIM expenditures. Results Changes in average molecule prices were associated largely with biosimilar uptake. For molecules with relatively high biosimilar uptake (>60%), prices fell considerably (−21.2% to −59.3%) one year after exclusivity milestones, whereas molecules with lower biosimilar uptake (<10%) experienced smaller price decreases (−2.4% to −8.4%). Average price reduction at the molecule level after biosimilar entry was not significant (−18.6%; p = .657). When applying the RDD results after adalimumab’s exclusivity milestones, its projected share of total TIM market expenditures decreased from 48.0% in 2019 to 26.0% in 2025, whereas expenditures on Janus kinase inhibitors increased from 4.0% to 34.0%. Conclusions Biologics facing biosimilar competition may experience price decreases, potentially offering substantial savings to payers, patients, and society, although the magnitude of these estimates depends on biosimilar uptake. Formulary placement, along with manufacturer-payer dynamics, may also play a role in determining the impact on price and market uptake of biosimilars.

Analysis of Patent and Regulatory Exclusivity for Novel Agents in China and the United States: A Cohort Study of Drugs Approved Between 2018 and 2021

Patent and regulatory exclusivity shall constitute incentives for pharmaceutical companies to develop new drugs. This study aims to investigate the differences in the patent term extension (PTE) and regulatory exclusivity between China and the United States, and to evaluate their potential impact on the market exclusivity period of novel drugs. Small-molecule novel drugs with their first indication approved in China and the United States between 2018 and 2021 were evaluated regarding their PTE and regulatory exclusivity. The PTE length of the China-approved drugs was calculated by simulation, whereas that of the US-approved drugs was extracted from the United States Patent and Trademark Office. Thirty-two and 107 novel drugs approved in China and the United States, respectively, were included in the study. The PTE length of the US-approved drugs calculated by the China-PTE method was significantly longer than that calculated by the US-PTE method. Patent extensions should be granted for 91% of new drugs in China and 82% in the United States. The simulated median PTE length of novel drugs approved in China was significantly higher than that of the United States (5.0 vs. 2.9years, P<0.05). It can be expected that the implementation of the PTE policy in China would significantly extend the period of market exclusivity for novel drugs similar to that of the United States. China should fully evaluate the potential impact of the PTE policy on the market exclusivity of novel drugs and provide better incentives to the development of novel drugs in addressing unmet clinical needs when developing its regulatory exclusivity policy.

Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020.

Inhalers are the mainstay of treatment for asthma and chronic obstructive pulmonary disease (COPD). These products face limited generic competition in the US and remain expensive. To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action. More than half of all patents were on the inhaler devices, not the active ingredients or other aspects of these drug-device combinations. Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another ("device hops"). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.

Patents, Data Exclusivity, and the Development of New Drugs

Abstract Pharmaceutical firms enjoy market exclusivity for new drugs from concurrent patent protection and exclusivity of the clinical trials data submitted for market approval. Patent invalidation during drug development renders data exclusivity the sole source of protection and shifts the period of market exclusivity. In instrumental variables regressions, we quantify the effect of a one-year reduction in expected market exclusivity on the likelihood of drug commercialization. The effect is largely driven by patent invalidations early in the drug development process and by the responses of large originators. We provide estimates of the responsiveness of R&amp;D investments to market exclusivity expectations.

Knowledge and Perceptions of Generic Drugs: A Cross Sectional Study

Generic medicines are pharmaceutical products usually intended to be interchangeable with the originator brand product, manufactured without a license from the originator manufacturer and marketed after the expiry of patent or other exclusivity rights. The current potential economic benefits associated with their use have been exponentially rising and thus, generic medicines are a significant approach to reduce the massive expenditure on medicines. Governments are thus emphasizing on and promoting the usage of generic medicines. However, negative perceptions of their quality influence use and raise issues of certainty and trust in medications. The objective of this study is to identify consumers in terms of their perceptions towards branded and generic medicines in the country. A cross - sectional study was conducted with consumers of various age demographics and location factors. Using convenience sampling, survey forms were distributed to them via social media platforms. For a period of 30 days, 236 respondents had participated in the survey. Assessments of the results were conducted on qualitative data to develop an insight into the perception of medicines amongst the masses. The survey confirmed that generic drug awareness was considerably high among younger age groups than older respondents. An overwhelming 78% respondent understood that generic medicines are cheaper than branded medicines. Regardless, 34.8% of respondents who were aware of generic drugs did not realize that they were less expensive than brand-name drugs. The survey conducted showed a high support for generic substitution. Furthermore, it indicates that programs should be implemented in order to boost generic drug prescriptions by medical practitioners.&#x0D; Keywords: generic, branded, awareness, healthcare, survey

The Cost-Effectiveness of Therapeutic Drug Monitoring (TDM) of Generic Imatinib for the Treatment of Chronic Myelogenous Leukemia

INTRODUCTIONA recent clinical study of using therapeutic drug monitoring (TDM) of imatinib mesylate (IM) for the treatment of chronic myelogenous leukemia (CML) found that the cytogenetic response at 12 months was significantly improved with IM TDM (Rousselot, P. et al. Blood 2015 126:133).Given that tyrosine kinase inhibitors (TKI) other than IM had previously shown more rapid molecular responses at standard doses, the improved IM efficacy using TDM provides new clinical information when selecting a CML treatment.A recent cost-effectiveness analysis of TKI for CML found that, when considering the pending loss of patent exclusivity of IM, using IM as a first-line treatment is the most cost-effective treatment option. However, since the loss of patent exclusivity, no studies have considered the cost-effectiveness of IM since the loss of patent exclusivity, nor has the cost-effectiveness of IM TDM been evaluated. OBJECTIVEThe objective of the study was to determine the cost-effectiveness of using generic IM TDM for the first-line treatment of CML. METHODSA peer-reviewed and published TKI cost-effectiveness model in the CML (Padula, WV, et al. JNCI, 2016 Mar 4;108(7)) was modified to include IM TDM as a treatment option. Efficacy inputs for major molecular response (MMR) rates were taken from published clinical studies: IM TDM 65%, dasatinib 52%, nilotinib 53% (Kantarjian H, , et al N Engl J Med. 2010;362:2260-2270; Kantarjian HM, et al. Blood. 2012;119:1123-1129. Larson RA, et al. Leukemia. 2012;26:2197-2203).Using the Federal Supply Schedule and average and lowest wholesale acquisition cost as price bases, alternative estimates were used for drug prices including generic IM. The cost of TDM for IM was added to the IM TDM comparator arm at $228 annually (6 tests at $38 each) over the 5-year time horizon. Other input costs were updated to 2016 U.S. Dollars using the Medical Service index of the Consumer Price Index.A U.S. payer perspective was used with a 5-year time horizon and a 3.0% discount rate. The model compared first-line IM TDM versus first-line IM alone, first-line dasatinib or nilotinib (D/N) in terms of costs, quality-adjusted life-years (QALYs), and cost-effectiveness. Univariate (one-way) and multivariate (two-way) sensitivity analysis was performed on all key clinical and economic parameters. RESULTSThe model found that IM TDM dominates IM alone with $15,452 to $36,940 in savings and 0.25 higher QALYs. Using an FSS price basis, per patient total costs for IM and IM TDM were $270,905 and $233,965, respectively. For WAC average pricing, these costs were $461,657 and $446,205, respectively, and for the lowest WAC pricing, these costs were $366,966 and $350,090, respectively.The results comparing first line using of IM TDM to D/N found that IM TDM had slightly higher QALYs and lower costs (0.08 QALYs, and $117,006 to $172,420 savings per patient [varying by price basis]). Thus, in terms of cost-effectiveness, IM TDM dominates D/N with both lower costs and higher QALYs.The model also found that for each first-line IM TDM patient responding for 5 years $114,577 to $207,564 was saved versus patients receiving first-line D/N. Sensitivity analysis confirmed that the results are robust. CONCLUSIONThe analysis found that IM TDM dominates IM alone and D/N under a wide range of price scenarios. The analysis suggests that IM TDM is both a clinically and economically viable first-line treatment option for CML. DisclosuresSalamone:Saladax Biomedical, Inc: Employment, Equity Ownership. Becker:Saladax Biomedical, Inc.: Consultancy. Padula:Saladax Biomedical, Inc: Research Funding.

Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures

Prescription drug spending in the US requires policy intervention to control costs and improve the value obtained from pharmaceutical spending. One such intervention is to apply cost-effectiveness evidence to decisions regarding drug coverage and pricing, but this intervention depends on the existence of such evidence to guide decisions. To characterize the availability and quality of cost-effectiveness studies for prescription drugs with the greatest Medicare Part D spending. In this national cross-sectional analysis, publicly available 2016 Medicare drug spending records were merged with 2016 US Food & Drug Administration Orange Book data and the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. All studies published through 2015 that evaluated the cost-effectiveness of the 250 drugs for which Medicare Part D spending was the greatest in US-based adult patient populations were included. Data were analyzed from September 2018 to June 2020. The presence and quality of published cost-effectiveness analyses for the 250 drugs for which Medicare Part D spending was greatest in 2016 were assessed based on the inclusion of key cost-effectiveness analysis elements and global ratings by independent reviewers for the Tufts CEA Registry. Medicare Part D spending on the 250 drugs in the sample totaled $122.8 billion in 2016 (84.1% of total spending). Of these 250 drugs, 91 (36.4%) had a generic equivalent and 159 (63.6%) retained some patent exclusivity. There were 280 unique cost-effectiveness analyses for these drugs, representing data on 135 (54.0%) of the 250 drugs included and 67.0% of Part D spending on the top 250 drugs. The 115 drugs (46.0%) without cost-effectiveness studies accounted for 33.0% of Part D spending on the top 250 drugs. Of the 280 available studies, 128 (45.7%) were industry sponsored. A large proportion of the studies (250 [89.3%]) did not meet the minimum quality requirements. In this cross-sectional study, a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. The lack of quality analyses may present a challenge in efforts to develop policies addressing drug spending in terms of value.

Use of budget savings from patent expiration of cancer drugs to improve affordability and accessibility

BackgroundThe introduction of generics after the loss of patent exclusivity plays a major role in budget savings by significantly decreasing drug prices. The aims of this study were to estimate the budget savings from off-patent cancer drugs in 2020–2024 and to inform decision makers on how these savings could be used to improve the affordability of innovative cancer treatments in South Korea.MethodsA model was developed to calculate budget savings from off-patent cancer drug use in Korea over 5 years (2020–2024). Cancer drugs with one or more valid patents that expire between 2020 and 2024 in Korea were selected. Key input parameters in the model included market share of generics, market growth, and prices of originators and generics. To reflect market dynamics after patent expiration, the trends of the off-patent market were estimated using historical sales volume data of IQVIA from 2012 to 2018. The study assumed that the prices of off-patent drugs decreased according to the price regulations set by the Korean government and that the off-patent market sales volume did not grow. Sensitivity analyses were performed to investigate the uncertainty in model input parameters.ResultsA total of 24 cancer drugs which met selection criteria were identified. In the base case analysis, patent expiration of cancer drugs between 2020 and 2024 could lead to a spending reduction of ₩234,429 million ($203 million), which was 20% of the cancer drug expenditure in the 5-year period. The savings ranged from ₩157,633 million ($136 million) to ₩434,523 million ($376 million) depending on the scenarios in sensitivity analyses.ConclusionsThe findings indicate that patent loss of cancer drugs could lead to a 20% reduction in spending on cancer drugs over the next 5 years in South Korea. The savings could be used to improve the affordability of innovative, advanced cancer drugs for 94,000 cancer patients by reallocating the budget savings from patent expiration.

Prospecção tecnológica de patentes de curativos depositados no Brasil de 2009 a 2018

O objetivo do deste estudo foi realizar uma prospecção para avaliar o depósito de patentes desses produtos no banco de dados do Instituto Nacional de Propriedade Industrial (INPI), identificando curativos depositados na base de patentes no Brasil dos últimos 10 anos, e verificar quais os depositantes com maior registro de patentes e distribuição segundo a Classificação Internacional de Patentes. A pesquisa ocorreu através da prospecção de patentes no banco de dados INPI compreendidos nos anos de 2009-2018. Foram encontrados 187 depósitos de patentes e após exclusão das patentes duplicadas, resultou em 55 pedidos. Os depósitos foram classificados quanto ao país, empresa, universidades e depositantes independentes, os quais as empresas apresentam maior número de depósitos de patentes relacionados a curativos. Em primeira instância, foram separados quanto à Classificação Internacional de Patente (CIP), apresentando mais resultados referente a de Esterilização e desinfecção do ar, de material para curativos e artigos cirúrgicos, e depois quanto à apresentação dos curativos, tendo como maior registro os adesivos. Conclui-se com o referido estudo, que empresas estrangeiras são as que mais têm depósitos de patente. No Brasil, foi observado que pessoas físicas e universidades investem mais em pesquisa. Além disso, observou-se que houve uma diminuição de documentos depositados ao decorrer dos anos, o que pode ser atribuído à crise financeira mundial que afeta os investimentos em pesquisas.

Recognizing barriers to entry of biosimilars in the United States market and highlighting the solutions

Drugs that are procured from living cells and are used to treat acute and chronic diseases are called biologics, whereas biosimilars are the drugs which are highly similar but not identical to the original reference product. The main advantage of these drugs is that they are highly targeted with great therapeutic activity and can be used for multiple indications. Despite all the advantages biologics are still extremely costly. The main purpose of developing and introducing biosimilars was and is to increase market competition leading to a decrease in the cost of the biologics. However, until now the cost of the treatment has not decreased in the US market because there are many barriers to the entry of biosimilar in the US market which are discussed in this article. In this article, we argue that the barrier or hurdle in the US market entry of the biosimilars is not only limited to patent protection or exclusivity but other less discussed barriers are also there which are to be discussed. Due to these barriers till June 10, 2020, only 9 biosimilars are available commercially in the US market out of the 27 biosimilars approved for marketing by the U.S. Food and Drug Administration (FDA). We argue that the introduction of these biosimilars in the US market is essential for increasing market competition and thus decreasing the overall treatment cost for both the government and the payers. In this article, we are also providing perspective on the possible solutions to reduce these barriers and to encourage the entry of biosimilar in the US market.

A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation.

Biologic agents have revolutionized the management of serious health conditions in the last two decades. The use of “targeted therapy” brings not only better progression free survivals and overall survivals, but also better toxicity profiles and quality of life benefits, compared to empirical palliative chemotherapy. However, given the high cost associated with biologic drugs and the sharp increases in biologic drug utilization, this drug category has significantly raised healthcare cost over the years. A similar phenomenon was previously experienced with branded simple chemical compound drugs, including chemotherapeutic agents, which was largely mitigated by the introduction of a generic approval pathway, decreasing the costs of the drugs, making them more affordable, given to the increase in competition among the drug makers. A similar opportunity presents years later with the completion of the full patent exclusivity period of many biologics. However, the ending of patent exclusivity, although enables more market competition, does not guarantee market penetration. Stakeholders, such as patients, providers and payers, must build trust and confidence in the science of biosimilars and the product specific studies leading to FDA approval in order to incorporate these products to practice and enable the biosimilar market at large to reach the potential to significantly contribute to reductions in drug cost. Dissemination of scientific and emerging biosimilar evidence is paramount in order to support stakeholder informed decision making and enable each to benefit from expanded treatment options. This paper describes the biosimilar development, approval process, and reviews a number of challenges with the marketing implementation of biosimilars.