India’s Emcure to manufacture Roche’s biologicals
Roche has reportedly made a deal with India-based Emcure Pharmaceuticals to produce its blockbuster anticancer drugs Herceptin (trastuzumab) and MabThera (rituximab) for India and other developing markets. This is a change in strategy for Swiss drug giant Roche, which has rigorously defended its patent rights against Indian generic drug makers in the past.

Source: The Economic Times

Second biosimilar G-CSF in Japan
Nippon Kayaku and Teva are apparently following in the footsteps of Mochida Pharmaceuticals and partner Fuji Pharma. The latter announced on 26 December 2011 that they had filed respective applications for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan. Nippon Kayaku and Teva filed for approval of their biosimilar G-CSF (TKN732) with Japan’s Pharmaceuticals and Medical Devices Agency on 15 March 2012.

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First biosimilar G-CSF in Japan

Source: SCRIP

FDA biosimilars guidance and IP protection
As originator companies start to think about how they can produce biobetters of their blockbusters in order to extend their life, the next question is what to patent and what to keep as a trade secret, according to IP experts. The advantage with a trade secret is that these can last 100 years or more. When compared to a measly 20 years of patent protection, this looks like a very attractive option.

Source: Mass High Tech