The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

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’.

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

“…The European Medicines Agency (EMA) pioneered the legal framework and regulatory approval pathway for biosimilars in 2005, paving the way for other jurisdictions around the globe (Gherghescu and Delgado-Charro, 2020). In alignment with the International Council for Harmonization (ICH) guidelines, the EMA's "Guideline on Similar Biological Medicinal Products" states that similarity to the innovator needs to be established in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive, head-to-head biosimilarity exercise for characterization of the quality of the DP and the approval is subjected to the totality-of-evidence presented (EMA, 1996(EMA, , 1999(EMA, , 2005CHMP, 2005CHMP, , 2014.…”

Coupling CRISPR interference with FACS enrichment: New approach in glycoengineering of CHO cell lines for therapeutic glycoprotein production

“…Biosimilar market entry promotes competition, which lowers overall healthcare costs and makes these otherwise costly types of drugs more accessible. [ 7 ] The rising number of biosimilar approvals in the EU and US drives the competition between developers of innovative biologics and biosimilars. [ 3 ] To stay competitive, both sites are constantly seeking approaches that enable faster and more cost‐effective drug development.…”

On the Use of Surface Plasmon Resonance-Based Biosensors for Advanced Bioprocess Monitoring

“…Biomanufacturers are subject to strict directives imposed by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States and the European Medicine Agency (EMA) in Europe, to ensure their products are fit to the highest standards of quality, efficacy, and safety. The biotherapeutic market of today is rapidly growing and evolving, with notable contributions attributed to the rise of therapeutic monoclonal antibodies [1] and expiring patents allowing the creation of more and more biosimilars [2].…”