Biosimilar regulation in the EU

Kurki, Pekka; Ekman, Niklas

doi:10.1586/17512433.2015.1071188

Cited by 20 publications

(11 citation statements)

References 22 publications

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“…The regulatory framework applicable to biosimilar medicines is well-defined both by European Medicines Agency (EMA) and the Food and Drug Administration. [18][19][20][21][22] This framework includes some specific concepts, such as the indication extrapolation rules enabling the approval of a biosimilar medicine for all the clinical indications of the reference medicinal product, solely based on the results of the indication assessed in clinical trials and upon adequate scientific justification. However, the concept of biosimilarity and related issues about the manufacturing process, extrapolation of indications, substitution by the pharmacist, etc., may be questioned by both health professionals and patients.…”

Section: Introductionmentioning

confidence: 99%

Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: Results of a French web-based survey

Beck

Michel

Rybarczyk-Vigouret

et al. 2016

mAbs

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This study's aims were: 1) to extract a comprehensive overview of the knowledge, experience and opinions of both community pharmacists and hospital pharmacists regarding biosimilar medicines in France; and 2) to identify the perceived problems and solutions to promoting their prescription. A 2015 web-based survey was conducted by the Observatoire des Médicaments, des Dispositifs Médicaux et de l'Innovation Thérapeutique of Alsace. A total of 802 pharmacists responded to the survey. Many (536, 66.8%, [95% confidence interval (CI) 63.6-70.1]) indicated that they were not familiar with biosimilars. Half of community pharmacists (95% CI 42.7-57.3) stated that they were not at all informed about biosimilar drugs, compared with 15.7% (95% CI 12.9-18.6) of hospital pharmacists. Almost all respondents (781, 97.4%, [95% CI 96.3-98.5]) had at least one pending question on biosimilars. Most of the questions were related to the manufacturing process, safety, substitution rules and the international non-proprietary name prescription. At the time of the study, 467 pharmacists (58.2%, [95% CI 54.8-61.6]) had already validated a prescription for a biosimilar drug, mainly for filgrastim. These latter were more comfortable in explaining the benefit of biosimilar medicines to the patient. Pharmacists were rather favorable to biosimilar drugs, and about 9 of 10 quoted healthcare cost savings as incentives to their prescription. However, many did not agree with allowing biosimilar substitution. "Patients' wishes to be treated with the originator" and "indication extrapolation" were the two main constraints identified. The survey highlighted the need to provide French pharmacists with accurate and comprehensive information regarding biosimilar medicines.

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Section: Introductionmentioning

confidence: 99%

Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: Results of a French web-based survey

Beck

Michel

Rybarczyk-Vigouret

et al. 2016

mAbs

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“…The aim of which is to avoid uncertainties regarding the level of characterization achievable, and the possible clinical consequences of differences in physical-chemical characteristics, such as the amount of impurities. 14,15 Regulatory agencies require a Phase 1 (pharmacokinetic/pharmacodynamic) trial and at least one Phase 3 clinical (randomized controlled) trial to demonstrate the equivalent efficacy, safety, and immunogenicity of the biosimilar to those of the reference agent. The equivalence trial design needs to be conducted on patients with a disease for which the reference agent is licensed, whereas the pharmacokinetic/pharmacodynamic study may be conducted on healthy individuals.…”

Section: How Does a Biosimilar Get Approved?mentioning

confidence: 99%

<p>Biosimilars to Antitumor Necrosis Factor Agents in Inflammatory Bowel Disease</p>

Sulais

AlAmeel

2020

BTT

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Anti-tumor Necrosis Factor (anti-TNF) agents are the backbone treatment of moderate to severe cases of inflammatory bowel disease. One of the main drawbacks of these agents is the high cost. The introduction of biosimilar products to anti-TNF agents is expected to lower the cost. Health care providers ought to be aware of the available data that addresses the safety and efficacy of biosimilars in IBD patients. This article outlines the current evidence-based data regarding the available biosimilar products, their safety, efficacy and how to deal with patients' concerns.

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“…However, guidance regarding interchangeability, switching, and substitution of a reference product with a biosimilar is determined by individual EU member states . To date, no EU‐approved biosimilars have been withdrawn or suspended because of safety concerns …”

Section: Regulatory Approval Of Biosimilars: Global Versus Latin Amermentioning

confidence: 99%

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Castañeda‐Hernández

Sandoval

Coindreau

et al. 2019

Pharmacoepidemiology and Drug

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Purpose This review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs. Methods We reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars. Results Many Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs. Conclusions The main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

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Biosimilar regulation in the EU

Cited by 20 publications

References 22 publications

Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: Results of a French web-based survey

Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: Results of a French web-based survey

<p>Biosimilars to Antitumor Necrosis Factor Agents in Inflammatory Bowel Disease</p>

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

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