US biosimilar pathway unlikely to be used: developers will opt for a traditional BLA filing

Claudia Wiatr
BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy 2011 February 1, 25 (1): 63-7
In March 2010, the US passed the healthcare reform bill, including The Biologics Price Competition and Innovation Act of 2009, which established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars. The aBLA pathway may never be used. At the "Business of Biosimilars" meeting in Boston in September, developers of both innovator and generic biologics as well as representatives from the scientific, regulatory, and legal communities noted that, because of unclear requirements for clinical data and the need for public disclosure of proprietary data, manufacturers of generic biologics are unlikely to take advantage of the aBLA process, opting instead for a standard Biologic License Application (BLA). The implications of an unusable biosimilars pathway in the US dampen our already soft outlook for biosimilars. Companies will still develop follow-on biologics, but approved compounds will behave as new branded drugs. Biosimilars in the US are therefore not likely to lead to aggressive pricing, but will more likely mirror current situations where several similar biologics are available. For example, the interferon (IFN) β-1a products Avonex® and Rebif®, and Betaseron® (IFN β-1b) have all enjoyed >10% price increases for the last several years in spite of their clinical similarities. inThought reiterates its outlook for generic erosion of a typical biologic that projects a loss of revenue of 30% over 5 years compared to the 90% revenue loss for a typical branded small molecule.

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