Last month, the Food and Drug Administration (FDA) approved the first U.S. biosimilar, Zarxio (filgrastim-sndz). Since the positive vote of FDA’s Oncologic’s Drugs Advisory Committee at its January meeting, approval of Sandoz’s biosimilar to Amgen’s Neupogen for all 5
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.
Latest from Biosimilars Law Blog - Page 2
Netherlands MEB revises position on biosimilars and interchangeability
The Dutch Medicines Evaluation Board (MEB) published a new position on biosimilars, in which it accepts substitution or interchangeability of biosimilars under certain conditions.
The MEB’s revised position on biosimilars was published on 31 March 2015 and replaces its previous…
FDA Issues Draft Guidances on Reference Product Exclusivity for Biological Products and Clinical Pharmacology for Biosimilars
As biosimilar applications begin rolling in, FDA has issued two of its 2014 “promised” guidances, addressing important issues of how the agency is implementing the BPCIA: (1) what information FDA will consider to determine “first licensure” for a biologic licensed…
FDA Anticipates New Draft Biosimilar Guidances
Including biosimilars in the release of expected 2014 CDER draft guidance documents has sparked the public interest as industry, physicians, patients and others await additional cues on FDA’s implementation of the BPCIA. The Center for Drug Evaluation and Research’s 2014…
Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs
Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September. Authorization of Remsima represents the first monoclonal antibody biosimilar, and the thirteenth biosimilar,…
FDA Activities During Government Shutdown
The U.S. Food and Drug Administration staff will continue User Fee supported activities and vital consumer protection activities during the government shutdown. FDA staff, including review divisions and chief counsel’s office, will continue work on regulatory activities covered by user…
GPhA Petitions FDA Not to Distinguish Biosimilars by Unique Non-Proprietary Names
The Generic Pharmaceutical Association requests that the U.S. Food and Drug Administration assign the same non-proprietary name to a biosimilar as the one held by its reference biologic. FDA has not articulated a policy for naming of biologics, biosimilars and…
EMA releases a draft revision to the Biosimilars Guideline for public consultation
The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in…
Universities urge FDA to require certification of information exchange for biosimilar applications
A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA. The concern raised…
If you missed the Maximizing Patent Life Cycles panel discussion, you may want to read this
By David Fox
I recently participated in the American Conference Institute panel discussion “Maximizing Patent Life Cycles,” which was moderated by Pfizer Associate General Counsel Geoffrey Levitt. In case you missed it, “The Pink Sheet” covered the event in its article “FDA…
