On June 24, 2017, Hogan Lovells attorneys Xin Tao (Washington DC Office) and Liang Xu (Beijing Office) spoke at the 15th Annual Conference of the Sino-American Pharmaceutical Professionals Association – Greater Philadelphia’s annual conference. Mr. Tao presented on the “Biosimilar
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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Supreme Court Issues Landmark Biosimilar Ruling
On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and is expected to significantly impact the…
Guide to Recent Biosimilar Activity by FDA and in the Supreme Court
The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability.…
FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process
The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the issues raised in the petitions. FDA’s denial letter indicates that biosimilar labeling guidelines are still in flux while FDA works to…
AIFA publishes “Second Concept Paper” on biosimilars
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended
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Biosimilar switching: Dutch MoH announces the set-up of a national system for biological medicinal products
The Dutch Minister of Health (MoH) announced the set-up of a national system to trace the safety of biological medicinal products. The MoH expects an increase in the number of biosimilar prescriptions. The national system should contribute to a responsible use…
FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings
FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving protein products currently approved under the drug statute (section…
FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars
AbbVie Challenges FDA Biosimilar Labeling
In a citizen petition, AbbVie has challenged the Food and Drug Administration’s (FDA’s) approach to biosimilar labeling, as implemented in the agency’s recent approval for Zarxio (filgrastim-sndz) as a biosimilar to Neupoen (filgrastim). As we previously blogged, the…
FDA Updates U.S. Biosimilar Guidances
Five years after enactment of the BPCIA and following its first biosimilar approval, the U.S. Food and Drug Administration finalized its initial guidances describing the scientific and regulatory expectations for biosimilar approval under the 351(k) pathway.
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