Regulatory evaluation of biosimilars throughout their product life-cycle

Abstract

The World Health Assembly in 2014 adopted a resolution that recognized the importance of increasing access to biotherapeutic products, of improving their affordability and of ensuring their quality, safety and efficacy. Biosimilars are biotherapeutic products similar to already licensed reference products and are usually developed after patents on the original products have expired. Their introduction into the market is likely to reduce the costs of medicines substantially, thereby improving the availability of treatment for patients. However, there are barriers to market access for biosimilars. This article discusses the factors that give rise to these barriers and explains the importance of regulatory oversight throughout the product life-cycle of biosimilars. The paper also describes the role regulators can play in increasing confidence in biosimilars use by: (i) establishing regulatory oversight of biosimilars throughout their life-cycle, from development to post-licensing oversight, and ensuring that only high-quality, safe and efficacious biosimilars are available on the market; (ii) ensuring regulatory authorities have adequate capacity to assess and monitor the quality, safety and efficacy of biosimilars throughout their life-cycle; and (iii) monitoring the use of biosimilars in public health systems in collaboration with other stakeholders.

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

“…Approval could be facilitated via a collaborative review that was executed by other regulatory authorities or through a previous expert review. Furthermore, approvals of biosimilars that were obtained from regulatory authorities possessing the appropriate expertise could stand as a strong reference to these expert reviews [44]. The ‘Adaptive Designs for Clinical Trials of Drugs and Biologics’, a draft guidance that was recently made available by FDA for the industry, describes the important principles for designing, conducting, and reporting the results from an adaptive clinical trial to provide evidence of the effectiveness and safety of a drug or biologic.…”

“…Regulatory authorities should be legalized to monitor the impact of biosimilars in public health systems in collaboration with other stakeholders. To assist, WHO has established global standards to ensure the quality, safety, and efficacy of biotherapeutics, including biosimilars, at all stages of their life-cycle [44]. These standards posit themselves as a strong basis for mutual recognition of regulatory oversight and for regulatory convergence at the global level.…”

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

“…Up to now, the FDA has approved five trastuzumabs, two bevacizumabs, four infliximabs, six adalimumabs, two rituximabs, two etanercepts, two filgastrims, four pegfilgrastims, and one epoetin alfa [ 11 ]. The World Health Organization (WHO), by issuing several guidelines for biosimilars (or as they call them “similar bio therapeutic products”), keeps trying to align regulatory aspects for developing and approving biosimilars across countries [ 6 , 12 , 13 , 14 ]. In 2019 there are 95 approved biosimilars in use worldwide [ 2 ].…”

Current perspectives on biosimilars

“…To appreciate why these terms do not apply to biosimilars, it is important to understand the definition of a biosimilar. Although the definition of “biosimilar” is not globally standardized between regulatory agencies, a comparison of how the regulatory agencies define the term biosimilar reveals significant resemblance between them:US FDA [53]: “A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.”EU EMA [5]: “A biosimilar is a biological medicine highly similar to another already approved biological medicine.”WHO [31]: “Similar biotherapeutic product (SBP). A biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.”…”