Biosimilar Penetration Research Articles

Uptake of biosimilars in China: a retrospective analysis of the case of trastuzumab from 2018 to 2023

BackgroundThe Chinese biosimilar industry has demonstrated rapid growth in recent years. Limited evidence is available about biosimilar uptake at the national level. This study aimed to assess biosimilar uptake in the case of trastuzumab and to explore potential factors influencing the biosimilar penetration at national and provincial levels.MethodsThis study employed an interrupted time series analysis to assess the level and trend changes of national trastuzumab originator consumption and the overall trastuzumab consumption after the price reduction of the originator and the introduction of the first biosimilar using the China Hospital Pharmacy Audit procurement data from March 2018 to February 2023. A latent class trajectory model (LCTM) was also adopted to estimate the biosimilar penetration across 30 provincial-level administrative divisions (PLADs). Based on the LCTM grouping results, provincial characteristics were analyzed.ResultsAfter rapid growth, the penetration of biosimilars demonstrated a moderate ascending trend at the national level, reaching 27% in February 2023. Following the introduction of the first biosimilar in July 2021, the consumption of the originator decreased by 0.5% per month (P = 0.008), and the growth rate of overall trastuzumab consumption decreased by 1.1% per month (P = 0.014). LCTM fit the best when the number of trajectory classes was two, dividing 30 PLADs into a group demonstrating a faster increase in biosimilar penetration and the other with a slower increase. The PLADs in the fast-increasing group had a higher proportion of the population covered by the national basic health insurance, a lower proportion of the urban population, a lower proportion of the population covered by the urban employee health insurance program, a lower gross domestic product per capita, a lower total health expenditure per capita, and a lower out-of-pocket expenditure.ConclusionsThe uptake of trastuzumab biosimilars in China was lower compared with major European countries. The introduction of trastuzumab biosimilars presented a substitutional effect. Perceptions of physicians and patients, the medicines procurement model, competition from other biologics, and health insurance payment methods may influence biosimilar uptake. Enhancing a comprehensive understanding of biosimilars among physicians and patients, including biologics with biosimilars in the national pooled procurement, and implementing provider payment reforms could foster biosimilar penetration.

Comparison of Two Financial Incentives to Encourage the Use of Adalimumab Biosimilars: Results of a French Experiment Close to Clinicians.

In 2018, the French government introduced two mutually exclusive financial incentives to increase etanercept and insulin glargine biosimilar use. The general case redirects 20% of the price difference between the reference product and its biosimilars to hospitals for every biosimilar dispensed in community pharmacies from hospital prescriptions. The experimental case redirects 30% to prescribing clinical units after hospital selection. Adalimumab was added to these incentives in 2019, after its first biosimilar was launched. This retrospective observational study aimed to compare both general and experimental incentives after 19 months to assess the impact of directly incentivizing clinical units for adalimumab biosimilars. The monthly number of adalimumab boxes dispensed in community pharmacies was linked to the corresponding hospital's prescription using IQVIA Xponent data from November 2017 to October 2020. The monthly mean rate of adalimumab biosimilars was compared between incentive groups and subgroups depending on hospitals' prior experience with the etanercept experimental case. General case hospitals had a significantly lower mean biosimilar uptake (16.7% vs 23.2%, p = 0.029) than those included in the experimental case. Twenty-three of the 40 hospitals in the experimental case and ten out of the 91 hospitals studied in the general case had already taken part in the etanercept experiment. Biosimilar uptake was higher, but not statistically significant, for hospitals with prior experience in the adalimumab general case group (p = 0.086). This study confirmed that incentivizing close to physicians was more effective in increasing the biosimilar rate. It also suggested that previous incentive experience positively influenced biosimilar penetration.

Unveiling the Biosimilar Paradox of Oncologists' Perceptions and Hesitations in South Korea: A Web-Based Survey Study.

Biosimilars offer a cost-effective alternative to original biopharmaceuticals with comparable efficacy and safety. The perception and familiarity of prescribers toward biosimilars play a critical role in their market penetration. Yet, few studies have explored the perception of oncologists toward biosimilars, much less in Asia. The objective of this study is to understand barriers of adopting biosimilars among oncologists and explore strategies to promote their use in clinical practice settings. A web-based survey was conducted among Korean oncologists from September to October 2022, assessing their perception of biosimilars and prescribing practices. Among the 118 surveyed oncologists, 75.4% (89 out of 118) had previously prescribed biosimilars. When asked about their preference, 48.3% (57 out of 118) of the respondents preferred originators to biosimilars, whereas 16.1% (19 out of 118) favored biosimilars over the originators. The primary reason for preferring the originators was trust in safety and efficacy (94.7%, 54 out of 57). Still, a paradox was noted as 87.0% (47 out of 54) and 85.2% (46 out of 54) of these also acknowledged the comparable efficacy and safety of biosimilars. A relatively small number of the respondents (16.1%, 19 out of 118) did not consider prescribing biosimilars to biologic-naïve patients at all, and up to 56.8% (67 out of 118) expressed reluctance to switch prescriptions from originators to biosimilars. However, 90.7% (107 out of 118) of respondents considered changing their prescription to biosimilars if patients faced financial stress. Concerns regarding the efficacy when switching to biosimilars were expressed by 42.7% (38 out of 89) of oncologists with biosimilar prescribing experience, increasing to 69.0% (20 out of 29) among those without such experience. Korean oncologists perceived biosimilars to be as safe and effective as originators. However, there is a notable mismatch between this perception and their prescribing practices, particularly among those who have not prescribed biosimilars before. The financial burden of patients served as a significant driver for prescribing biosimilars, yet marginal price differences between originators and biosimilars may be associated with the low adoption rate of biosimilars in Korea. Active price competition may enhance market penetration of biosimilars.

Biosimilars engage in low levels of direct-to-physician marketing relative to reference biologics.

Biosimilars have the potential to greatly reduce US spending on biologic drugs, but uptake of these competitor products varies. We used Open Payments data from 2014 to 2022 to proxy for direct-to-physician marketing and compared levels of activity between biologic and biosimilar drug manufacturers. Our analysis focused on 6 reference biologics that recently faced competition in the years immediately before and after the launch of the first biosimilar. We used Medicare Part B dosage units to measure market penetration of biosimilars and its relationship with biosimilar marketing activity. Last, we conducted a sensitivity test, comparing payments for primarily office- or hospital-based physicians, using affiliations constructed from Medicare Carrier claims. Reference biologic manufacturers greatly reduced the amount of direct-to-physician marketing in the post-launch period. Biosimilar manufacturers generally engaged in low levels of activity relative to the historic performance of reference biologics. These trends were consistent across office- and hospital-based physicians. The intensity of biosimilars' direct-to-physician marketing also had no apparent relationship with achieved market penetration. Our findings demonstrate that persistently high market shares of reference biologics cannot be explained by ongoing direct-to-physician marketing activities. At the same time, while such activities could educate physicians or induce switching, biosimilar entrants engaged in little direct-to-physician marketing.

What About Offering a Financial Incentive Directly to Clinical Units to Encourage the Use of Biosimilars? Results of a Two-Year National Experiment in France.

Regarding the low penetration of biosimilars in the French market, in 2018, the government introduced two mutually exclusive financial incentives to increase biosimilar use. They redirect 20% (general case) or 30% (experimental case) of the price difference between the reference product and its biosimilar to hospitals for every biosimilar delivered in retail pharmacies from these hospital prescriptions. The experimental case specifically targets prescribing clinical units. Our study aimed to assess whether the new payment scheme closer to physicians (experimental case) improved etanercept biosimilar penetration after 25 months. We evaluated hospital prescriptions using IQVIA Xponent data. The monthly number of etanercept boxes delivered in retail pharmacies was linked to the corresponding hospital prescription. The impact of the experimental case on the etanercept biosimilar rate was assessed by a difference-in-difference method. Among the 39 hospitals studied in the experimental case compared with the 169 belonging to the general case, a similar growing trend of etanercept biosimilar use was observed before October 2018. At the start of the experiment, there was an acceleration of biosimilar penetration in the experimental group, until both groups reached a plateau. A significant double difference estimator of 9.72 percentage points in favor of the experiment confirmed this (p<2.2.10-16). The French experimental incentive appeared to be more effective at increasing biosimilar use. As it is expected to be implemented in all hospitals, the knowledge gained during this testing phase should allow adjustment of some of its terms and increase physician engagement.

TNF-alpha inhibitors biosimilar use in France: a nationwide population-based study using the French National Health Data System

TNF-alpha inhibitors have revolutionized the therapeutic care in chronic inflammatory diseases. Several biosimilar products were commercialized at their patent expiry, substantially decreasing the cost of treatment. This longitudinal descriptive study aimed at assessing infliximab, etanercept and adalimumab biosimilar penetration rates using data of the French National Health Data System. A total of 207,118 new or prevalent users from the date of first biosimilar commercialization in France (respectively January 2015, May 2016 and October 2018) were included in the study and followed until September 30, 2021. Biosimilars represented respectively 78%, 46% and 53% of the overall initiations, and 94%, 66% and 60% last year’s initiations. A total of 46%, 19% and 17% of originator product prevalent users switched for a biosimilar during the follow-up. Biosimilar penetration rate was much higher for infliximab than for its counterparts, due to its hospital delivery modality. Biosimilar initiation and originator-to-biosimilar switch tended to be observed more in rheumatology than in the other specialties. Biosimilar use was mostly consistent across patient socio-demographic characteristics. Biosimilar initiation rate increased rapidly from their market arrival and originator-to-biosimilar switch rate remained moderate, highlighting the need and usefulness of political action and biosimilar use tracking.

The inexorable increase of biologic exposure in paediatric inflammatory bowel disease: a Scottish, population-based, longitudinal study.

The use of biologics in paediatric-onset inflammatory bowel disease (PIBD) is rapidly changing. To identify the incidence and prevalence of biologic use within Scottish PIBD services, and to describe patient demographics and outcomes for those patients who required escalation of therapy beyond anti-tumour necrosis factor alpha (anti-TNFα) agents METHODS: We captured a nationwide cohort of prospectively identified patients less than 18 years of age with PIBD (A1 phenotype; diagnosed <17 years of age) within paediatric services over a 4.5-year period (1 January 2015-30 June 2019). All patients who received infliximab, adalimumab, vedolizumab or ustekinumab during the study period and/or received their first dose of these biologics were audited retrospectively. Scotland-wide PIBD-prevalence cases increased from 554 to 644 over the study period. A total of 495 incident new-start biological therapies were commenced on 403 PIBD patients: 295 infliximab (60%), 161 adalimumab (32%), 24 vedolizumab (5%) and 15 ustekunumab (3%). The proportion of new-start biologics changed with infliximab initiation rates decreasing (87%-54%) while adalimumab (13%-31%), vedolizumab (0%-9%) and ustekinumab (0%-6%) all increased. The incidence rate (first dose of new biologic not including biosimilar switch) increased from 6.9% to 8.1% over the study period and point prevalence rates (any biologic use) increased from 20.2% to 43.5% - an average annual percentage increase of 20%. Biosimilar penetration of new-start anti-TNFα agents increased from 3% to 91%. Demographics and outcomes of those patients receiving vedolizumab and ustekinumab were similar. Complete accrual of Scottish nationwide biologic usage within paediatric services demonstrates a rapidly changing, inexorably increasing PIBD biologics landscape.

The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia.

Background: The aim of this study was to investigate the impact of selected legislative initiatives and their implementation for off-patent medicinal products in Slovakia compared with the rest of the Visegrád Group (V4 countries). Methods: We analyzed the development of applications for the reimbursement of generic and biosimilar drugs. Particular emphasis was placed on a) the availability and penetration of biosimilars from 2006 to 2020 in Slovakia, b) a comparative analysis of biosimilars in V4 countries based on the national reimbursement lists of medicinal products for August 2021. Data relating to the sales of generic and biosimilar medicines in Czechia, Hungary, Poland, and Slovakia were based on the IQVIA MIDAS MAT July 2021. Results: The number of applications for the reimbursement of generic drugs decreased from 296 in 2016 to 165 in 2020. In financial terms, the sales of generic medicines in Slovakia increased from 21.7% in 2015 to 22.3% in 2020. Over the same period, the sales of generic drugs in Poland fell from 40.4% in 2015 to 35.0% in 2020, from 26.2 to 22.1% in Hungary, and from 29.6 to 20.4% in Czechia. When considering the 66 biosimilars registered by the European Medicines Agency 38 drugs (58%) were available on the Slovak market as of August 1, 2021; this compared to 32 drugs (48%) in Poland, 38 drugs (58%) in Hungary, and 40 drugs (61%) in Czechia. In financial terms, the sales of biosimilars in Slovakia increased from 0.94% in 2015 to 2.00% in 2020. Over the same period, the sales of biosimilars in Poland increased from 0.59% in 2015 to 1.29% in 2020, from 0.72 to 2.23% in Hungary, and from 0.76 to 2.15% in Czechia. Conclusion: To intensify the use of generic and biosimilar medicines, we suggest the comprehensive re-evaluation of combinations of the three-threshold entry, the amount of mandatory price reductions, and external reference pricing requirements (as the average of the three lowest prices among the official prices of a medicinal product in other Member States) for generic and biosimilar drugs. We also suggest cancellation of the exception from the fixed co-payment of the insured.

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database.

PurposeInfliximab, which was approved in 2002, had its first biosimilar launched in 2014 across Japan. However, the penetration rate of this biosimilar remains unclear given the limited data regarding its current clinical use throughout Japan. This study was conducted to describe the current clinical characteristics of patients receiving infliximab and the penetration rate of the reference infliximab and/or biosimilar infliximab using a Japanese administrative claims database.Patients and MethodsThis retrospective, descriptive study utilized the Japan Medical Data Vision database, a nationwide hospital-based database. Data on patients receiving infliximab recorded from April 2008 to March 2019 were extracted from the database. Patient characteristics of the reference and biosimilar infliximab groups and penetration rates according to fiscal year, target diseases diagnosis, and subsidy for intractable diseases were examined.ResultsA total of 9735 patients were extracted for analysis, among whom 92% (n=8950) and 8% (n=785) received only reference infliximab and its biosimilar, respectively. Both groups exhibited similar clinical characteristics. The biosimilar penetration rate increased from 0.8% in 2014 to 22.5% in 2018, with overall penetration rates throughout the period according to diagnosis (with or without subsidy) being 14.4% (with, 4.1%; without, 16.4%), 4.7% (with, 3.7%; without, 10.6%), 5.7% (with, 4.5%; without, 13.5%), and 7.5% (with, 4.4%; without, 8.2%) for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis, respectively.ConclusionBiosimilar infliximab is prescribed for patients with similar characteristics to reference infliximab. Despite the increasing penetration rates according to target disease, they remain much lower among patients receiving subsidy for intractable disease than among those who do not.

Legal Obstacles to Biosimilar Market Entry

Improving the market availability and penetration of biosimilars, “follow-on” versions of biologic products, will require attention to key legal obstacles. Because biosimilars offer the potential for sizeable cost savings to payors and improved access to biologic drugs for patients, obstacles to the timely licensure and market availability of biosimilars are of major public health significance. Issues around intellectual property, potentially anticompetitive contractual arrangements with purchasers and insurers, and laws governing automatic substitution of biosimilars for biologics merit particular attention. This Article examines several key legal obstacles to biosimilar market entry in the United States, including (1) the complexity and imprecise boundaries of the exchange of patent information codified in the BPCIA; (2) patent thickets that protect biologic reference products; (3) unsettled antitrust law surrounding reverse payment patent settlements (i.e., “pay-for-delay” agreements); (4) contractual arrangements such as bundled purchase agreements and formulary exclusivity provisions; and (5) state laws that regulate substitution of biosimilars for biologics at the pharmacy level. Strategies to address these obstacles include reforms to the patent system to curb issuance of ancillary secondary patents intended to delay competition, greater transparency around biologic patents, reconsideration of the need for a regulatory designation of interchangeability, and better detection and enforcement of deliberately anticompetitive practices.

Effective tools to manage biosimilars prescription: The Italian experience

IntroductionBiosimilars represent both a clinical and a financial opportunity. However, low biosimilar penetration has been observed across Europe. Italy has registered a high and increasing biosimilars uptake, but not uniform across regions. ObjectivesThe paper aims to describe different managerial tools that can be leveraged to exploit the biosimilars’ potential. A focus on Italy and the Tuscany region will be specifically carried out. Furthermore, this research is intended to propose some preliminary considerations about the most effective measures to support biosimilars’ uptake. MethodsThis article is based on both desk research and on action research. A desk research was carried out to explore the existing international and national literature on the measures implemented to promote biosimilars’ penetration. The action research concerned a longitudinal cooperation project between the Management and Health Laboratory of Scuola Superiore Sant'Anna of Pisa and the Drugs and Appropriateness Policy Sector of Tuscany Region. The activity saw the direct involvement of the Management and Health Laboratory in supporting the regional pharmaceutical governance in managing biosimilars’ penetration. ResultsSeveral demand and supply side policies to foster biosimilar penetration have been implemented both at national and regional levels. In Italy, most regions have adopted specific biosimilar policies at different moments and with heterogeneous contents. The Tuscan Regional Health System implemented three main measures: formal top-down, bottom-up and “mixed” measures. The strategy was effective in increasing biosimilar uptake. The success is probably associated with its comprehensive approach and to the coherence of the different measures it was composed of.

Biosimilars of monoclonal antibodies in inflammatory diseases and cancer: current situation, challenges, and opportunities.

The approval pathway for biosimilars of monoclonal antibodies in theEuropeanUnion is aimed at ruling out the presence of significant differenceswith the original biological in quality attributes, efficacy, immunogenicityand safety. It also provides the rationale for extrapolating the evidenceobtained with a biosimilar in at least one indication to the rest of theapproved indications of its original biological, thus simplifying the developmentprogramme of biosimilars. Biosimilars of monoclonal antibodiesavailable in the European Union for the treatment of inflammatory diseasesand cancer have fulfilled all the requirements for approval, and manyof them have additional evidence available. Moreover, real world dataconfirms the safety and efficacy of these drugs in the indications they arebeing used for. In Spain, many scientific societies endorse the regulatorypathway of biosimilars and acknowledge their role in the efficiency of thehealthcare system. Even so, some barriers remain that limit their use. Theimplementation of different measures at the patient, prescriber, institutional, and national levels might increase the penetration of biosimilars, freeing up resources that may be invested in other therapies and, potentially, boost innovation.

P797 The inexorable increase of biological exposure in paediatric inflammatory bowel disease: a Scottish population-based, longitudinal study 2015–2019

Abstract Background The use of biologics in paediatric inflammatory bowel disease (PIBD) is rapidly changing with the introduction of new mode of action medications, cheaper biosimilar alternatives, improved convenience with home care options and an increasing focus on early intensified management. No nationwide paediatric data is available to objectively capture this shifting landscape and its effect on healthcare resources. We aimed to identify the incidence and prevalence of biologic use within Scottish PIBD services. Methods In Scotland, specialist paediatric gastroenterology, hepatology and nutrition (PGHAN) services are coordinated through three tertiary academic centres (Glasgow, Edinburgh and Aberdeen) which act as regional referral hubs covering all district general hospitals. A nationwide cohort of prospectively identified PIBD cases less than 18 years of age with paediatric-onset IBD (A1 phenotype; diagnosed &amp;lt;17 years of age) were captured within paediatric services over a 4.5-year period (01.01.2015–30.06.2019). All patients who received infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) or ustekinumab (UST) during the study period (prevalent cases) or received their first dose of these biologics (incident cases not including biosimilar switches) were retrospectively audited. Point prevalence was calculated on 30 June each year and period prevalence as 6 month epochs. Results In total 495 incident new start biological therapies were commenced on 403 PIBD patients over the study period; 295 IFX (60%), 161 ADA (32%), 24 VDZ (5%), 15 UST (3%). The proportion of new start biologics changed over time with IFX initiation rates decreasing (87–54%) while ADA (13–31%), VDZ (0–10%) and UST (0–6%) all increased. Biosimilar penetration of new start anti-tumour necrosis factor (anti-TNF) biologics increased from 3% to 91% by 30.06.2019. The overall number of prevalent PIBD patients increased from 554 to 644 over the study period. Point prevalent rates of current biologic therapy usage increased from 20.2% on 30.06.15 to 43.5% on 30.06.19; an average annual percentage increase of 29%. Conclusion Complete accrual of Scottish nationwide biologic usage within paediatric services demonstrates a rapidly changing PIBD treatment landscape with a significant increase in biologic therapy (from 20% to 43% in just 4 years), a near-complete shift to biosimilar anti-TNF and use of biologics with new modes of action which are as yet unlicensed for PIBD.

PBI57 PAYER AND PHYSICIAN DYNAMICS SURROUNDING BIOSIMILAR ACCESS IN THE EU

Since the first biosimilar was approved in the EU in 2006, their uptake has been highly debated in the region which is often regarded as pioneer in the adoption of biosimilars. The objectives of this research were to examine the dynamics between payer policy and HCPs’ prescribing practice on the uptake of biosimilars in the EU5. Secondary research analyzed policies that may impact biosimilar access and uptake in each EU5 country (France, Italy, Germany, Spain and the U.K.). 20 payers who influence policy and/or access to biologics at a local/regional or national level were interviewed to discuss pricing and access expectations for biosimilars. Concurrently, a 1-week virtual advisory board with 30 HCPs (oncologists, gastroenterologists and rheumatologists), was conducted to ascertain perceptions and prescribing patterns for biosimilars. Molecules of interest included adalimumab, EPOs/filgrastim, etanercept, infliximab, insulin glargine, and rituximab. The consensus among participating payers and physicians is that biosimilars are equivalent to originators. Therefore, it is unsurprising that price is the main driver for adoption of biosimilars throughout Europe. Price discounts relative to the originator biologic varied by country, and generally ranged ∼30-60%. The payer-reported range of discounts achieved across molecules also varied, ranging from 26% for rituximab in Germany to 56% for insulin glargine in Spain. Despite the larger discounts achieved by some biosimilars, their market penetration lags behind anticipated uptake, suggesting other driving forces at play. EU5 payers discussed the implementation of incentivization policies (e.g. gainsharing agreements) and financial targets to further encourage biosimilar use; however, most HCPs mentioned having no prescribing obligations currently. This research indicated that discounts alone, although the main driving factor, are not sufficient to realize the potential cost-savings of biosimilars; therefore, compulsory substitution and incentive-based policies, implemented in parallel, may drive greater market penetration of biosimilars across the EU5.

PBI55 FUTURE TRENDS ON THE BIOSIMILAR UPTAKE IN THE EU5 AND THE US

Biosimilar use creates an opportunity for increased patient access, drug competition and cost-savings, especially in a landscape driven by imminent patent-expiration of biologics. Study aimed to assess anticipated trends and incentives to enhance biosimilar uptake in the United States (US) and Europe’s big 5 (EU5: France, Germany, Italy, Spain, the United Kingdom). Targeted literature review was conducted in Medline/Embase, complemented with desk research. Differences in supply- and demand-side policies for biosimilars are impacting global market uptake. Successive policy shifts are seen following collection of biosimilar switching evidence and continuous debate to support further penetration of biosimilars to generate more economic savings. In France, biosimilar use became a part of the health strategy (2018-2022), aiming to achieve 80% of biosimilar penetration in 2022. Although automatic substitution was introduced by law in France (2014), it is still not implemented due to the lack of a published decree. In Germany, a bill allowing biosimilar substitution by pharmacists awaits for the legislative approval since 2018; due to criticism and revisions, implementation of this reform will be postponed by 3 years. Meanwhile, G-BA was mandated to introduce a list of interchangeable biosimilars to support physician-authorised switching. In Spain and the UK, hospital pharmacy stocking of a one preferred drug over tendering for multiple products is expected. Real-world evidence for Italy shows the increasing trend for biosimilar use with great variability among regions. Despite infancy in the US biosimilar uptake, the FDA released the Biosimilars Action Plan (2018) outlining 11 key actions to boost the biosimilar industry and facilitate access, with a guideline for demonstrating interchangeability (2019). Even though market share of biosimilars remains low, with except to some drug-tendering processes, regulations are evolving rapidly and a number of tools should be implemented in the near future to boost the biosimilar uptake in the following years.

The impact of implemented regulations on biosimilars in Slovakia

ObjectivesThe aim of this study was to review legislative provisions for the reimbursement of biosimilars, assess the impact of the implemented regulations on access to biosimilars, and to calculate the lost opportunity for savings due to the limited availability of biosimilars in Slovakia. MethodsThe Slovak legislation concerning the reimbursement of biosimilars was reviewed. The reimbursement dossiers of medicines, health technology assessments and appraisals, justification of the reimbursement decisions, final reimbursement decisions and all aspects of the appeal mechanisms are transparently published on the website of the Slovak Ministry of Health (http://kategorizacia.mzsr.sk/Lieky), and these were used for this analysis. ResultsOnly 14 reimbursement dossiers were submitted for biosimilars between 2006 and September 2018 in Slovakia. In 2016 and 2017, no reimbursement dossiers were submitted. The results, based on data provided by wholesalers who are legally obliged to deliver information to the State Institute for Drug Control, showed that the Slovak health budget could save €28.26-€39.56 million per year if biosimilars with marketing authorisations were available in the Slovak market, and a 25–35% decrease in price compared with that of biological medicinal products. ConclusionsOur findings show that proactive strategies and policies should be implemented to increase availability and penetration of biosimilars on the Slovak pharmaceutical market to reduce societal losses that are caused by the lack of biosimilar medicines availability.

Regulatory and Clinical Perspective on Biosimilars: a Comparison of the US and European Experiences

Purpose of Review The purpose of the review is to explore the reasons for low penetration of biosimilars in the United States (US) and to compare and contrast the US and European experiences.

PBI6 EVALUATION OF THE COST SAVING POTENTIAL OF INTRODUCING AN ADALIMUMAB BIOSIMILAR FOR THE TREATMENT OF ALL LICENSED ADULT ADALIMUMAB INDICATIONS IN FRANCE

Biologics, such as adalimumab, are efficacious in reducing disease activity in their authorised indications but are considered costly treatment options. The study’s objective was to assess the budget impact of introducing an adalimumab biosimilar within France for all licensed adult adalimumab indications. A budget-impact model (BIM) was used to estimate the cost saving potential over various timeframes through competitive biosimilar pricing from the payer’s perspective. The current adalimumab-treated population was estimated through GERS data and assumed to be volume stable over the measured period. The BIM scenario was developed for an adalimumab biosimilar vs the reference biologic product price comparisons aiming for an ultimate total market share of 80% at the discounted prices. The adalimumab price adoption was modelled to be of a linear uptake comparing three separate periods (6,12 and 24 months) with a 20, 30 and 40% discount from published price sources as well as an immediate switch of 80% of the available market volume. The immediate conversion of the market to these new discounted prices could bring potential savings of €35.5m, €53.3m and €71m over 24 months whilst linear conversion programmes could generate savings of €18.5m, €27.7m and €37m over the same period. Six- and twelve-month linear transitions against discounted pricing above, whilst limiting total market penetration to 43% at these points, could potentially release savings of €20.7m, €31m and €41.5m and €19.2m, €28.9m and €38.5m respectively. The introduction of adalimumab biosimilar price competition represents substantial cost-saving potential for healthcare systems within France. The proposed transition outlined would support France’s aim to reach 80% biosimilar penetration by 2022 through implementation of the Article 51 policy. Capacity of health systems may limit the larger cost savings potentials in the short term although linear uptake programmes limit the degree of savings over more aggressive conversion scenarios.

Biosimilars for Psoriasis—Experience from Europe

Over the last several years, major changes have occurred in Europe regarding the use of biosimilars. Some countries such as Norway, Denmark, and the United Kingdom (UK) have a relatively high market penetration of biosimilars, whereas in other European countries, biosimilar uptake is low. The objectives of this review are to describe the use of biosimilars in selected European countries, using “real-life” information from members of the International Psoriasis Council (IPC) who are key opinion leaders in dermatology. The use of biosimilars for patients with psoriasis is continuously discussed and reviewed by the IPC, through in-person meetings by members of the Biosimilar Working Group (BSWG). In preparation for this paper, we surveyed the use of biosimilars for patients with psoriasis through European BSWG members, who were asked to describe the situation in their countries. The survey collected information from each IPC councilor regarding the use of biosimilars currently on the market, guidelines for interchangeability, traceability, and naming of these agents. In addition, information regarding pricing, access, and physician/patient education was obtained. The status of biosimilars was discussed at an IPC biosimilar working group roundtable event which was held in Stockholm on June 28th, 2018. With increased use of biosimilars likely in the future, the IPC will continue to provide leadership, education, and guidance for dermatologists to maximize the challenges presented by the adoption of biosimilars into clinical practice and improve the choice of biologic treatment for patients with moderate-severe psoriasis.

The economic impact of biosimilars in Italy: a scenario analysis

Background: the first generation of biotechnology drugs is reaching, or has already reached, the patent expiry and a large number of biosimilars is entering the Italian pharmaceutical market. The objective of the analysis was to evaluate the economic impacts of biosimilars on the national health expenditure in Italy between 2014 and 2020. Methods: Based on the information deriving from consumption per standard unit and equivalent patients, it was estimated monthly expenditure for some of the biological drugs currently available in Italy that have had or will have a patent expiry within the analysis period (infliximab, etanercept, adalimumab, insulin glargine, trastuzumab, rituximab, bevacizumab and insulin aspart). Pharmaceutical expenditure was calculated on hospital sales prices net of transparent discounts required by law and visible from the AIFA database. Three alternative scenarios have been developed based on the perceptions of a board of clinical experts, pharmacologists and pharmacoeconomists involved in the study. The experts involved analyzed the estimates of treated patients between 2014 and 2017 and reports their hypothetical biosimilar penetration during the period 2018-2020. The results were represented as the difference between the estimated expenditure in the absence of biosimilars and the estimated expenditure in the presence of biosimilars with the real or hypothetical biosimilar penetration. Results: considering the standard units dispensed for each year, the economic model estimate an annual expenditure in 2014 equal to € 1.47 billion for the molecules considered in the analysis. These estimates rise to € 1.54, € 1.50 billion and € 1.51 billion during 2015, 2016 and 2017 in the scenario without biosimilar introduction. Biosimilar introduction generates cost savings between € 3.8 million in 2015 and € 32.9 million in 2017 if compared with the scenario without. Assuming an increasing biosimilar penetration between 2018 and 2020, scenario analysis estimates a cumulative cost reduction equal to € 597 million. Conclusions: Overall, biosimilar penetration generates important cost reduction that could be re-invested in the National Health Sistem.