Regulation of biosimilar medicines and current perspectives on interchangeability and policy

Abstract

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.

Medication safety risks to be managed in national implementation of automatic substitution of biological medicines: a qualitative study

“…Instead, in the USA, interchangeability of biologics is considered as an extension of the biosimilar status including additional clinical switching studies 65. In states where legislation allows, pharmacist can substitute products with interchangeability status 65 66. Substitution is allowed in some other countries, for example, in France and Australia 67.…”

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

“…In this regard, it is believed that biosimilars can accelerate the rheumatic disorders drug market competition, positively impacting the global health-care system though improved health-care affordability and increased patients' access to effective and safe drugs (13,15) However, despite the cost-savings potential of biosimilar drugs, there is still uncertainty as to whether currently marketed biosimilar drugs are equivalent to reference molecules in terms of e cacy, safety, and immunogenicity. Besides, the switching and interchangeability between biologics and biosimilars drugs are still topics of great debate in the treatment of RA (16)(17)(18)(19)(20).…”

Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

“…Despite the fact that biologics are a great opportunity for millions of patients worldwide, they are still not suffi ciently accessible in many countries (Cohen et al, 2019;Hoen, 2016). The main barrier is price as biologics are extremely expensive (Chen et al 2018;Lu & Jacob 2019, O'Callaghan 2019Kawalec et al, 2017;Olszewska, Adamski & Czarnecka-Operacz, 2018). Biologics have been on the pharmaceutical market for decades.…”