The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

GTC Biotherapeutics goes for a Regulatory Double Combo Shot

GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute. 

AgResearch will develop genetically modified animals capable of producing the building blocks for “biosimilar” versions of existing products that will begin coming off U.S. patent in 2014.

The double combo shot:  the success of the collaboration depends on

  1. a continuing trend of GE animal approvals, as well as
  2. the successful introduction of a biosimilars pathway in the U.S., (which is called for in Obama’s budget).

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