Abstract
Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.
Highlights
Introduction and Food and Drug Administration (FDA)Pharmaceutics 2021, 13, 48.Biological therapies have revolutionized care for many patients with chronic conditions, whilst putting a financial strain on healthcare systems that provide these expensive therapies and, in some instances, on patients themselves
The authors acknowledge the following limitations of the study: (a) This work represents a snapshot of the biosimilar approval landscape in December 2019 and no updates subsequent to this date were included in the analysis; (b) To the authors’ knowledge, all relevant information from the FDA and EMA repositories was gathered but the manual data-mining process precludes absolute certainty; (c) This study focused primarily on the patterns of approvals of biosimilars and other crucial factors determining patient access to these medicines were not included [2,21,22,23]; (d) The study focused on biosimilars approved by the EMA centralized procedure and those approved by national competent authorities were not included; (e) Whilst the trends shown are based in the data gathered
Had received 65 biosimilar marketing authorizations applications (MAAs) including those subsequently granted, withdrawn, or rejected, and the EC (European Commission) had issued a MA (Marketing Authorization) for 55 BS products following a positive opinion by the CHMP (Committee for Medicinal Products for Human Use) of the EMA
Summary
Introduction and FDAPharmaceutics 2021, 13, 48.Biological therapies have revolutionized care for many patients with chronic conditions, whilst putting a financial strain on healthcare systems that provide these expensive therapies and, in some instances, on patients themselves. As patents and exclusivity periods for the bio-originators expire, the development of biosimilar medicines can grow the biotherapeutic market and improve patient outcomes by facilitating access to biological therapies. According to Mehr, “these emerging biotherapeutics are perceived as major tools to control cost and increase access to biologic drugs” [1]. Biosimilars (BS) are biological medicines that are highly similar to an already-approved biologic, called the reference product (RP). The World Health Organization (WHO) refers to them as similar biotherapeutic products (SBPs) and defines them as ‘highly similar to an original biotherapeutic product’ [3] and ‘developed and assessed according to the regulatory guidelines that ensure an adequate comparison of the SBP with its RBP’ [3]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
