Viropro, Inc. (VPRO)

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FDA seeks increase funding for biosimilar drugs initiative

FDA will develop a pathway called 'Protecting Patients Initiative' for approving biosimilars, which are biological drugs shown to be highly similar to, and without clinically meaningful differences with, an FDA-approved reference biological product. Such biosimilars may also be shown to be interchangeable with the FDA-approved reference biological product.

These biosimilars offer the potential of significant savings for government and private sector healthcare systems that provide care to millions of Americans. The Protecting Patients Initiative also strengthens FDA efforts to modernize and improve safety throughout the supply chain of medical products, and it contains other resources to assure the safety of medical products.

Teva Pharmaceutical Industries Ltd. is testing a copy of Roche’s second-biggest-selling drug Rituxan.

Spectrum Pharmaceuticals signed an agreement with Canadian partner Viropro to develop a version of rituximab ahead of its US patent expiration in 2015.

Novartis/Sandoz has a Phase II trial for its version of Rituxan (rituximab) and is focusing on patients suffering for rheumatoid arthritis.

LINK HERE
February 14th, 2011

http://cllcanada.ca/2010/index.htm