Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU)

Abstract

The market for biotechnology-derived medicinal products is evolving rapidly with the imminent entry of biosimilars. The development and approval of biosimilars represent a critical pathway to expanding access to biological therapies while maintaining high standards of safety, efficacy and immunogenicity profile because biosimilars are made in living organisms there may be some minor differences from the reference medicines.

In the US, biosimilars are regulated under the Biologics Price Competition and Innovation Act (BPCIA), which is part of the Affordable Care Act. The regulatory pathway emphasizes a stepwise approach, involving analytical studies, preclinical assessments, and comparative clinical trials to establish biosimilarity with a reference product. The FDA assesses the totality of evidence provided by the biosimilar applicant to make a determination on safety, purity, and potency.

In the EU, the approval process for biosimilars is governed by the European Medicines Agency (EMA). The regulatory framework relies on a robust comparability exercise, emphasizing extensive analytical studies and well-designed clinical trials to establish biosimilarity. The EMA assesses the comprehensive data package submitted by the biosimilar applicant, considering the totality of evidence before granting marketing authorization.

While the overall approach is similar, there are nuanced differences in the regulatory processes. The US typically requires a more prescriptive approach to clinical trials, with the expectation of conducting at least one confirmatory comparative clinical trial. In contrast, the EU may allow for a more tailored approach to clinical development, recognizing that the need for extensive clinical trials may vary depending on the nature of the biosimilar and the reference product.

As the biosimilar landscape continues to evolve, ongoing collaboration and harmonization efforts between regulatory authorities aim to streamline global access to high-quality ,cost-effective biologic therapies.