FDA budget request for biosimilar drugs

[Guest guest]

The FDA has request a budgetary increase of $128 million for the development of

a program called " Protecting Patients Initiative'

FDA will develop a pathway 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.

Teva Pharmaceutical Industries Ltd. is testing a copy of Roche Holding AG's

second-biggest-selling drug Rituxan.

Spectrum Pharmaceuticals signed a pact with Canadian partner Viropro to develop

a version of rituximab ahead of its US patent expiration in 2015.

Novartis/Sandoz said the Phase II trial for its version of Rituxan (rituximab)

is focusing on patients suffering for rheumatoid arthritis.

Other biosimilars already available include a version of bendamustine and

lenalidomide.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243354.htm