The U.S. Food and Drug Administration released three draft Guidances on implementation of the Biologics Price Competition and Innovation Act of 2009. The Q&A, Scientific Considerations, and Quality Guidances cover the overall framework for biosimilar application requirements as envisioned by
Biosimilars Law Blog
The Biosimilars Law Blog, published by Hogan Lovells, focuses on legal developments and regulatory issues related to biosimilar products. It covers topics such as the Biologics Price Competition and Innovation Act (BPCIA), patent litigation and exclusivity for biosimilars, FDA guidance on biosimilar approval, interchangeability, and labeling, as well as international regulatory perspectives. The blog also discusses court rulings impacting biosimilar market entry and legal strategies for biosimilar applicants and reference product sponsors. It addresses the evolving landscape of biosimilar policy, clinical and legal considerations for biosimilar interchangeability, and the implications of biosimilar use in healthcare systems.
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EMA regulatory approval changes for biosimilars on the horizon in the E.U.?
As mentioned in a previous post, the EMA set the standard for regulatory approval of biosimilars* with the adoption of their overarching general guideline in 2005 (CHMP/437/04 — PDF), followed shortly thereafter by guidelines on quality issues (…
Biosimilars, biosimilarity—what does ‘highly similar’ mean?
It is largely up to the FDA.
In the U.S., what constitutes “highly similar” in the context of biosimilars is ultimately up to how the U.S. Food and Drug Admininstration applies the statutory language under the Biologics Price Competition and…
Why are generic drugs the ‘same’ and biosimilars only ‘similar’ to their corresponding reference products?
It’s the law and science.
The regulatory world of biological drugs is more complex and perhaps less clear than for the world of small molecule drugs. This is particularly true in the U.S. where, for historical reasons, biologics and small…
Global Dis-Harmonization of Biosimilar Naming and Labeling
The Food and Drug Law Institute held a recent “Dialogue” on the naming and labeling of biosimilars in the U.S. as the Food and Drug Administration (FDA) implements the abbreviated pathway for biosimilars authorized under the Biologics Price Competition and…