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Tag Archives: EMA

Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars

Reuters reports that the European Medicines Agency (EMA), which has already approved 13 biosimilars, is expecting to publish guidelines in November on biosimilar antibody therapeutics. EMA Executive Director Thomas Lonngren said that clinical trials will be required for antibody biosimilars (as they are for the products EMA has approved to date), but that requirements were likely to be less onerous than in the United States.

Reuters says that the small number of requests (six) received by EMA so far “reflects the difficulties of making such copycat medicines [antibodies]” but with the earliest therapeutic antibodies coming off patent (in Europe) in 2014, I expect these initial inquiries are just the tip of the iceberg. Of couse, biosimilars are hard (as we’ve noted); but a lucrative opportunity of that scale will not go untapped.

Meanwhile, as expected based on the draft notice leaked in September, the FDA is holding public meetings on the implementation of the Biologics Price Competition and Innovation Act (i.e., the biosimilars legislation). The full Federal Register notice (pdf) is up, and Mark Sernak at eyeonfda.com has extracted the questions posted for comment.

In addition to a long list of scientific and technical questions, there are a couple of inquiries that I’d highlight from a corporate law perspective:

  1. Which types of related entities may be ineligible for a period of 12-year exclusivity for a subsequent BLA, given the “potential transfer of BLAs from one corporate entity to another and the complexities of corporate and business relationships”; and
  2. Whether the existing fee structure under the Prescription Drug User Fee Act (PDUFA) should be considered as a model in establishing a user fee structure for biosimilar applications.

Interested in attending or in submitting a comment? The FDA’s meeting information page is here, and it includes webcast access for November 2 and November 3.

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