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Related Experiment Video

Updated: Jun 1, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Biosimilars: a regulatory perspective from America.

¹UMass Memorial Medical Center, Rheumatology Center, Memorial Campus, 119 Belmont Street, Worcester, MA 01605, USA. jonathan.kay@umassmemorial.org

Arthritis Research & Therapy

|May 19, 2011

Summary

Biosimilars, similar to approved biopharmaceuticals, are emerging globally. The US and EU have established abbreviated pathways for evaluating these complex biologic drugs, impacting market access.

Area of Science:

Biotechnology and Pharmaceutical Sciences
Regulatory Affairs

Background:

Biosimilars are highly similar protein-based products to existing reference biopharmaceuticals.
Development of biosimilars for tumor necrosis factor inhibitors and rituximab is active in Asia and Europe, with biosimilar etanercept already marketed in Colombia and China.
Existing US generic drug pathways (Section 505(b)(2)) are not suitable for complex large biopharmaceuticals.

Purpose of the Study:

To review and compare the regulatory approval processes for biosimilars in the United States (US) and the European Union (EU).
To highlight recent updates in US federal regulations pertaining to biosimilar drug approval.
To explain the abbreviated regulatory pathway for biosimilars established by the Biologics Price Competition and Innovation Act.

Main Methods:

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Review of US and EU regulatory guidelines and legislation concerning biosimilar drug approval.
Analysis of the Biologics Price Competition and Innovation Act (BPCIA) and its impact on the Public Health Service Act.
Comparison of the evaluation criteria for biosimilars, emphasizing the use of a single reference biological product.

Main Results:

The US and EU have distinct yet converging regulatory frameworks for biosimilar approval.
The BPCIA created an abbreviated pathway in the US, allowing for biosimilar evaluation based on comparison to a single reference product.
Recent changes in US federal regulations aim to streamline the approval process for these complex biologic medicines.

Conclusions:

The established abbreviated pathways in the US and EU facilitate the development and approval of biosimilars.
Understanding these regulatory processes is crucial for biotechnology companies and generic drug manufacturers.
The review provides insight into the evolving landscape of biosimilar regulation and market entry.