December 7, 2012

New Biosimilars Chapter by FLH Partner Brian J. Malkin Describes Biosimilar Challenges

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpgFLH Partner Brian J. Malkin's chapter in the 2013 Edition of Recent Developments in Food and Drug Law published by Aspatore / Thomas Reuters entitled: "Challenges to the Development of a Biosimilars Industry in the United States" is now available as a PDF copy. The chapter takes a hard look at the new biosimilars pathway created by the Biologics Price Competition and Innovation Act of 2009 ("the Biosimilars Act") and attempts to answer the question why no applicant appears to have filed a biosimilars application with FDA more than two and a half years after the Biosimilars Act was enacted. Some of the topics addressed include:



  • The Impact of the Biosimilars Act and Approval Issues for Biosimilars

  • Biological Innovator Challenges to Biosimilars

  • Interchangeability Issues

  • Biosimilar Manufacturing Issues

  • Patent Litigation and Confidentiality Issues

  • The FDA's General Approach Based on Its New Guidances

  • The FDA's Inverted Pyramid Approach

  • Enforcement/Pharmacovigilance Issues

  • Product Shortages, Liability, and Advertising Issues

  • Key Takeaways

Biosimilars are defined under the Biosimilars Act as "highly similar" to an innovator's biological product already approved by FDA. Biosimilars are also known around the world as follow-on biologics or biogenerics. Biosimilars are already approved in Europe and other countries and are clearly feasible given current technology and analytical methods. Ultimately, as there are less small molecule targets for generic companies to pursue over time, innovator and generic drug companies alike will be drawn to design, test, and file applications for biosimilars. FDA appears to have hoped that the new biosimilars pathway would create partnerships to form standards for analytic testing of biosimilars. Instead, the high cost and technical skills to reverse engineer the innovator's product and manufacture biosimilars has driven innovator and generic drug companies to form unique partnerships to develop proprietary analytical methods, including methods with either trade secret or patent protection.

Many expect these innovator-generic partnerships will create a different landscape of FDA applicants and intellectual property litigants, creating additional opportunities for conflicts. Larger generic drug companies, such as Teva, appear to have decided to file its biosimilars as full biologics license applications ("BLAs") rather than biosimilar applications, which FDA appears to have coined as "351(k) applications," referring to the new section in the Public Health Service Act for biosimilar applications. For example, Teva filed a full BLA for approval for filgrastim, which will compete as a separate--not interchangeable product--against the innovative product Neupogen® as early as November 2013 in accordance with announced settlement terms with Amgen, the BLA holder for Neupogen®. But just when the first biosimilar application will be filed in the United States and approved under the Biosimilars Act is anybody's guess.

It is hoped that innovator and biogeneric companies alike will benefit from the reflections and observations discussed by the author in the chapter. In particular, the author suggests FDA and industry should meet more regularly to help overcome the challenges posed in the chapter and otherwise inherently present in the Biosimilars Act, including the complex litigation pathway to overcome before marketing. In addition, it is suggested that more companies need to work together to make biosimilars a profitable and less costly alternative to innovator biologic therapies that cost in the hundreds of thousand and more per year per person.

Copies of the entire 2013 Edition of Recent Developments in Food and Drug Law may be obtained here.