Collected fees will be used to expedite the review process of biosimilar biological product applications, including post-market safety activities.
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This is not contradictory: the harder it is to launch a new biosimilar, the better Amgen will do in both markets.
The FDA action lags those in the European Union, which already has more than a dozen biosimilar drugs on the market.
Late yesterday, Amgen (AMGN) and Watson Pharmaceuticals (WPI) said they will partner to develop and commercialize several oncology antibody biosimilar medicines.
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Under the FDA agreement, the biosimilar application fee will be waived for a small business submitting its first biosimilar biological product application.
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The GPA noted in its commentary on the New York Times article that many companies who are developing biosimilar products also manufacture branded biologics.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
Bernstein analyst Ronny Gal, given the proportion of pharmaceutical revenues now generated by biologic products traditional generic drug manufacturers have little choice but to pursue biosimilar development.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
On its recent Q4 conference call with analysts Pfizer confirmed the likely progression of its own Herceptin biosimilar program into Phase III clinical trials later this year.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
The market share for biosimilar versions of anemia therapy erythropoietin is less than 13% in France, while in Germany it is 72%, according to IMS Health, a data firm.
The bottom line is that for the time being, from a regulatory perspective each biosimilar version of an approved biological product will be regarded as, in effect, a completely new and distinct drug.
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The FDA has yet to pass judgement on the subject of substitutable or interchangeable biosimilars, but consensus indicates that such a status could be conferred on a biosimilar if it is supported with more extensive clinical testing.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
The companies said the collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure and investment to ensure safe, reliably supplied therapies.
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The same can be said with biological drugs to treat RA. While the Enbrel patent may last until 2028, it is possible that biosimilar versions of other RA treatments will be available long before then and these will be cheaper.
The reality is that if the biosimilar opportunity fails to deliver the return on investment once projected, the impact will be felt far less on the balance sheets of Big Pharma companies, many of which will continue to derive considerable revenue streams from branded biologic products.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
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