Biosimilars: Evolving Challenges And Considerations

By Zoltan Gulyas, Thermo Fisher Scientific

It is a common misconception that biosimilar development is a less-complex process compared to novel biologics development. By the time of patent expiry and entry of biosimilars to the market, the innovator product has been used for years, demonstrating the efficacy and safety of the treatment. Biosimilar developers can leverage this experience: the regulatory framework enables an abbreviated clinical program that focuses on pharmacokinetics/pharmacodynamic (PK/PD) and immunogenicity assessments, but places emphasis on demonstrating high similarity to the reference product. The biosimilar candidate must be characterized by a wide variety of state-of-the-art analytical techniques, and all critical quality attributes (CQAs) must be comparable to the reference product.