Pharma & Outsourcing Practice: Biosimilars - Guidelines, Players, Providers

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  • Outsourcing for biosimilars
  • Approvals and guidance
  • Biosimilar monoclonal antibodies
  • Players and their responsibility
  • Service Providers

In Europe, 20 biosimilars have been reviewed to date, resulting in 14 approved products, with four and two products, respectively, using the same filgrastim; and three and two products, respectively, using the same erythropoietin. Two biosimilar products submitted for authorization have been rejected and four have been withdrawn. And only very recently, a Marketing Authorization Application (MAA) for the first biosimilar monoclonal antibody was submitted to the European Medicines Agency (EMA, formerly EMEA).

In the US, no products have been approved yet under a biosimilar pathway, but two have been approved under the 505(b)(2) regulatory pathway of the Federal Food, Drug, and Cosmetics Act: 1. Enoxaparin as the generic of Lovenox, a low-molecular heparin; and 2. Omnitrope, a generic of the growth hormone Genotropin.

Since March 2010, the US provisions for biosimilars have been defined via the Patient Protection and Affordable Care Act (PPACA). They are set out in PPACA Sections 3139 and 7001 to 7003. The latter sections are the “Biologics Price Competition and Innovation Act of 2009” (BPCIA), which inserts Sections 351(k), 351(l), and 351(m) into the Public Health Service Act (PHSA), introducing the approval pathway for biosimilars.

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