Use Of Biosimilar Medicines Research Articles

Potential for biosimilars in rheumatology in Africa

Biosimilars are products which are highly similar to a reference biologic product (RBP). In Africa, regulatory frameworks for biosimilar approval are still in development in many countries and few biosimilars...

Knowledge and attitude of community pharmacists toward biosimilar medicines: A cross-sectional study in Lebanon

ObjectivesPharmacists are drug experts who can play a significant role in promoting the use of biosimilar medicines. Therefore, the aim of this study was to assess community pharmacists' knowledge and attitude toward biosimilars in Lebanon, as well as potential factors influencing their knowledge. MethodsA descriptive, cross-sectional study involving licensed community pharmacists in Lebanon was conducted using random sampling between January and July 2022. An electronic survey consisting of 30-closed ended questions was used, it included 10 questions to assess participants knowledge towards biosimilars and 10 attitudinal statements. A knowledge score was then calculated. A multivariable analysis was conducted to determine predictors of knowledge using binary logistic regression including all variables with p < 0.20 on univariate analysis. Statistical significance was set at p value < 0.05. Key findingsIn total, 354 community pharmacists completed this survey. The majority of participants 261 (73.7%) were knowledgeable, with only 54 (15.3%) answering all the questions correctly. The results of the multivariable analysis showed only a statistically significant association between knowledge and pharmacists who had taken a course or post-graduate training course about biosimilar drugs (OR = 2.213, 95% CI = 1.088–4.500, p-value = 0.028). The majority of pharmacists 314 (88.7%) agreed with the statement “Healthcare professionals should be further educated to eliminate potential misconceptions and integrate biosimilars into routine clinical practice.” ConclusionsOverall, community pharmacists in Lebanon had a good knowledge about biosimilars that was significantly associated with post-graduate training courses. Additionally, our participants had a generally favorable attitude toward biosimilars.

AB043. Biosimilar medicines: a cross-sectional study on hospital pharmacists’ perceived confidence and barriers to promote prescribing among clinicians in Malaysia

Background: The use of biosimilar medicines offers potential cost savings in healthcare. As biosimilars become more widely available, pharmacists are better positioned to spearhead the appropriate and safe administration of biosimilars among clinical prescribers. Thus, we aimed to determine pharmacists’ perceived confidence and barriers towards promoting the use of biosimilars in clinical practice among clinical prescribers in Malaysia.

Policies to Encourage the Use of Biosimilars in European Countries and Their Potential Impact on Pharmaceutical Expenditure.

Introduction: Biosimilar medicines are considered promising alternatives to new biologicals with high price tags. The extent of savings resulting from biosimilar use depends on their price and uptake, which are largely shaped by pricing, reimbursement, and demand-side policies. This article informs about different policy measures employed by European countries to design the biologicals market and explores potential savings from the increased use of biosimilar medicines in Germany. Methods: Policy measures that target the price and uptake of biosimilar medicines were identified based on a prefilled questionnaire survey with public authorities in 16 European countries, who were the members of the Pharmaceutical Pricing and Reimbursement Information network (July 2020). Potential savings that could have been generated in Germany if different measures identified in the surveyed countries had been implemented were calculated for six publicly funded biological molecules. Price data of the Pharma Price Information service and German consumption data for 2018 were used for the calculation of five scenarios. Results: Several countries use a price link policy, setting the biosimilar price as a percentage of the price of the reference biological. Also lowering the price of the reference biological upon market entry of a biosimilar is less frequently used. While tendering of biosimilar medicines in the inpatient setting is the norm, it is rarely employed for biosimilars in outpatient use. Reference price systems and INN prescribing of medicines are the commonly used policy measures in the off-patent market, but some countries define exemptions for biologicals. Substituting biosimilars at the pharmacy level is rather an exception. Potential savings in Germany ranged from 5% (simple price link) to 55% (prices at the level of other countries) for the six studied molecules. Conclusion: Despite some differences, there are discernible tendencies across European countries with regard to their applications of certain policy measures targeting the price and uptake of biosimilar medicines. The potential for savings of some of these policies was clearly demonstrated. Monitoring and evaluation of these rather recent measures is key for obtaining a more comprehensive picture of their impact.

Management of the National Drug Administration Through the Use of Biosimilar Medicines. Expenditures, Numbers of Reimbursed Packages and Shares of Biosimilar Products in the Infliximab Market a Year Prior to and a Year after the Introduction of the National Drug Policy 2018–2022

Management of the National Drug Administration Through the Use of Biosimilar Medicines. Expenditures, Numbers of Reimbursed Packages and Shares of Biosimilar Products in the Infliximab Market a Year Prior to and a Year after the Introduction of the National Drug Policy 2018–2022

Biosimilar medicines for psoriasis. Positioning of the Mexican Academy of Dermatology.

The development and marketing of biosimilars opens a new scenario in the treatment of many pathologies, including psoriasis. This article reflects the position of the Mexican Academy of Dermatology (AMD) on the use of biosimilar medicines for the treatment of psoriasis in Mexico. In summary, the AMD estates that there is sufficient evidence to accept comparability of pharmacokinetics and pharmacodynamics of some biosimilar medicines to adalimumab, infliximab and etanercept; this evidence does not sufficiently support interchangeability or indication extrapolation. It is essential to establish a close pharmacovigilance not only to guarantee compliance with the Cofepris rules in Mexico, but also to facilitate the effective monitoring of the adverse effects of biosimilar medicines. Although the goal of biotechnological drugs is to achieve substantial savings for patients and public institutions, no economic criteria should prevail over rigorous scientific criteria that guarantee maximum therapeutic efficacy and optimum safety for patients.

Biosimilars in supportive care.

This review covers recent publications relating to the use of biosimilar medicines in the supportive care of cancer patients, and broader publications focussed on the benefits and challenges of implementing biosimilars into clinical practice. A metaanalysis and a number of systematic literature reviews have confirmed that the safety and efficacy of biosimilar versions of epoetin-α, filgrastim and infliximab are equivalent to those of their corresponding reference biologics. New guidelines have been issued concerning the interchangeability of biosimilars and the practice of substituting a biosimilar in place of a prescribed reference product. The introduction of biosimilars into a health system has been shown to improve patient access to treatment while also delivering cost savings, however, there are a number of barriers that can prevent or delay the adoption of biosimilars into clinical practice which must be overcome for the potential benefits of biosimilars to be realized. There is a large amount of data to demonstrate that supportive care biosimilars are well tolerated and effective, with over 10 years of experience in Europe. We can learn from the challenges faced when introducing biosimilars into supportive care to facilitate the introduction of newer biosimilars into the treatment setting.

A consensus statement on the use of biosimilar medicines in hematology in Australia.

Despite their availability for over a decade, the exact nature of biosimilar medicines is still poorly understood with paucity of clear treatment guidelines for their use in clinical practice in Australia. Although hematologists have had experience with biosimilars in the setting of supportive care, with the approval of the first biosimilar rituximab in hematological malignancies, it is important to revisit this topic. To inform the use of biosimilar medicines in clinical practice, we have developed a consensus statement from an Expert Panel of Australian hematologists, oncologists, and cancer pharmacists. These recommendations address the approach to use of biosimilar products in place of the corresponding reference medicine in a number of different clinical contexts. Our recommendations are based on the premise that biosimilar medicines can be considered therapeutically equivalent to their reference brand and used in a similar way to the reference product in any approved indication. We advocate for local approaches to the provision of patient information, dispensing of the intended brand and pharmacovigilance, to be developed in consultation with local hematologists and aim to improve confidence in the appropriate use of biosimilar medicines and their expected outcomes among hematologists.

Biosimilars: The Process &amp; Quality System Approach to Clinical Applications

Biosimilar medicines are highly similar to FDA approved reference biologics. The sponsor’s intended use claim plays an important role in the use of biosimilar medicines in specialty therapy categories such as immunology, endocrinology, oncology. The new biosimilar products approved by the FDA, play a pivotal role in the clinical treatments of patients suffering from life-threatening diseases such as cardiac myopathies, carcinoma, sarcoma, lymphoma. The US biosimilar approval process requires a thorough characterization of the new biosimilars with a clinically meaningful outcome. Sponsors of new biosimilars follow the appropriate ICH guidelines in regard to clinical PK/PD, safety and efficacy studies. The FDA guidances for extrapolation and interchangeability state that data derived from clinical studies should be adequate to demonstrate purity, potency, safety and the intended clinical use of the new biosimilar in comparison to previously approved licensed biologics. This article emphasizes the FDA’s quality system approach to the design of studies for clinical applications for designated specialty therapy categories.

PMU53 THE INCENTIVE FINANCIAL FRAMEWORK REGARDING FRENCH HOSPITAL PRESCRIPTION OF BIOSIMILAR MEDICINES WHEN DELIVERED IN RETAIL PHARMACY: IMPACT ANALYSIS OF ARTICLE 51 EXPERIMENTATION FOR 2018

In 2018, 40 million euros of savings were expected in France thanks to the interchangeability between reference biological medicinal products and biosimilars. In the measures proposed by the French State, the incentive financial framework regarding hospital prescription of biosimilar medicines when delivered in retail pharmacy in the context of the Article 51 experiment participate in these savings. The objective of this study is to evaluate, in France and for the year 2018, the financial impact of this experimental framework. To carry out this work, we first selected, with the help of the legal texts, the medicines and establishments participating in this experimentation. The data used for this exercise comes from the IQVIA Lifelink Treatment Dynamics® database and allowed us to perform the calculations presented in these texts. The results show a nonsignificant impact on the penetration rate of biosimilar drugs and show that there is a no significant savings for the community thanks to the experimental framework in 2018. The objective of obtaining a faster increase of at least 15 points of the biosimilar prescription rate in the establishment participating in the experiment, compared to non-participating establishment is not met. The objective of the general incentive scheme, which is to achieve a strong increase in the rate of use of biosimilar medicines (in 2018) compared to the initial rate (2017), is rather achieved. For all French establishment, penetration rates increased significantly compared to 2017 for both drug groups: + 8.5 points for the Anti Tumor Necrosis Factor group and + 7.3 points for the Insulin group. The entry of the Adalimumab group into the system will play a decisive role in the future savings generated by these incentives as early as 2019.

Regulation of biosimilar medicines and current perspectives on interchangeability and policy.

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.

Biosimilars in rheumatology: recommendations for regulation and use in Middle Eastern countries

The increasing availability of biosimilar medicines in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologic medicines. However, as well as a lack of real-world data on the use of biosimilar medicines in practice, the availability of intended copies in the region may undermine physician confidence in prescribing legitimate biosimilar medicines. There is a need for regional recommendations for healthcare professionals to ensure that biosimilar drugs can be used safely. Therefore, a literature search was performed with the aim of providing important recommendations for the regulation and use of biosimilar medicines in the Middle East from key opinion leaders in rheumatology from the region. These recommendations focus on improving the availability of relevant real-world data, ensuring that physicians are aware of the difference between intended copies and true biosimilars and ensuring that physicians are responsible for making any prescribing and switching decisions.

The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC).

A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.

Sustaining Cancer Care Through Collaborative Stewardship

Cancer care has undergone rapid changes in recent years, providing dramatically improved outcomes for many patients. However, these changes have resulted in substantial increases in the costs of care in some situations. This symposium brought together a multidisciplinary faculty of experts in oncology, patient advocacy, hospital pharmacy, and health economics to discuss current issues of affordability and improving patient access to oncology medicines. The aim of the symposium was to understand what value truly means with regard to cancer care, consider what could happen when the cost of cancer care becomes unsustainable, and propose solutions to ensure optimal cancer care now and in the future. In healthcare, it is no longer sufficient to demonstrate the effectiveness and cost-effectiveness of treatment. Now, issues of value, evidence-based decision-making, and quality must also be considered. The emerging paradigm of population and personalised healthcare was discussed by Prof Sir Gray, who highlighted the basic concepts of value-based healthcare and the need for improvement through collaborative systems and networks. The right of all patients to have equitable access to the best treatments and care was discussed by Geoffrey Henning. Among the potential solutions available, patient knowledge and empowerment will be of utmost importance, and co-ordinated campaigns by, and on behalf of, patients have the potential to change legislation for the benefit of patients. Prof Aapro considered how cost savings from the increased use of biosimilar medicines might be re-invested to improve access to other medications, and Jatinder Harchowal provided examples of how pharmacists can improve system-wide efficiencies, thus establishing and embedding value at a fundamental level. Finally, Prof Jönsson provided an overview of the burden, cost, and cost-effectiveness of cancer management, highlighting the growing importance of appropriate economic evaluations in the new paradigm of value-based healthcare. The session demonstrated that through the actions of patients and healthcare professionals as equal partners, a shift towards value-based healthcare and a culture of stewardship can be achieved. Importantly, these changes are necessary to safeguard the future sustainability of cancer care.

Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland

Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed. The majority of medical specialists (85%) and pharmacists (77%) claimed to be either very familiar or familiar with the term biosimilar, whereas many GPs (60%) were unable to define or had never heard of the term. One in five (21%) healthcare professionals responded that biosimilars were the same as generic medicines. The majority of medical specialists opposed pharmacist-led substitution of biological medicines but some thought it could be appropriate if agreed with the clinician in advance. Medical specialists who prescribe biosimilars (n = 43) were more likely to do so on treatment initiation (67%), than switch a patient from an originator medicine to a biosimilar (28%). The findings will aid the design of educational initiatives for healthcare professionals and highlight attitudes of healthcare professionals to biosimilars, so informing regulators, policy makers and industry.

PTU-059 Early Experience with Biosimilar Infliximab at a District General Hospital for an Entire Crohns Disease Patient Cohort Switch from Remicade to Inflectra

Introduction Switching from an established biologic to a biosimilar to save costs was considered likely to be ‘inappropriate and ineffective’ by ECCO.1 Methods With Area Prescribing Committee approval, all Crohns disease (CD) patients established on Remicade were provided with written and verbal information regarding the proposed switch, and all patients infused after April 2015 received Inflectra. Baseline calprotectin and Infliximab antibody and trough levels were undertaken. Harvey Bradshaw Indices (HBI) were assessed at every 8 week infusion. Results 21 CD patients were already established on Remicade treatment. 1 patient did not receive Inflectra as he was relapsing with high antibody and low trough levels. 4 other patients with high antibody levels (>10iU/L) did receive Inflectra, but increasing symptoms led to alternative immunosuppression in 3 of these patients (2 with Adalumimab, 1 with Allopurinol/Azathioprine). A decision was made just to stop infliximab in the 4’th pt as they were in full clinical remission. The results of the remaining 16 patients are illustrated below. Conclusion Although this is a small dataset, early results are encouraging. Patients understood the rationale behind the switch. There were no significant adverse events as a consequence of the switch. The majority of patients either remained in clinical remission or improved during the follow up period. The annual confirmed cost savings of £220,000 permitted investment in further IBD nurse monitoring (0.5 WTE) and allowed the introduction of infliximab trough and antibody testing which has certainly optimised and rationalised treatment decisions in these complex patients. Reference 1 Danese S, et al. ECCO position statement: the use of biosimilar medicines in the treatment of IBD. J Crohns Colitis 2013;7(7): 586–9. Disclosure of Interest None Declared