Abraxis Licenses Rights To Biosimilar From Indian Firm Biocon
Abraxis BioScience and Biocon have signed a licensing agreement that gives the Los Angeles firm the right to develop a biosimilar of granulocyte-colony stimulating factor in North America and the European Union, the companies announced July 19.
Under the agreement, Biocon, in Bangalore, India, will receive an upfront fee and, following approval in the U.S. and EU, royalties from Abraxis.
The deal marks Abraxis' initiation into follow-on biologic development, and "Biocon will do all the manufacturing," Abraxis told "The Pink Sheet" DAILY.
The biosimilar would compete with Amgen's G-CSF product Neupogen (filgrastim). Abraxis will develop the product first as a competitor for Neupogen in the European market, the firm said.
The biological activity of Biocon's G-CSF used in clinical trials was evaluated by the UK's National Institute of Biological Standards and Control, which provides independent testing of biologics. NIBSC found that the potency of the biosimilar met the necessary requirement, the Indian firm said. The drug has won approval of Indian authorities for treatment of neutropenia in cancer patients.
Separately, Biocon announced July 18 that it would divest its enzyme business to the Danish company Novozymes for approximately $115 million. The move allows Biocon to "continue its strategic focus within the biopharmaceutical business," Chairman Kiran Mazumdar-Shaw said.
In February, Seattle-based Cell Therapeutics announced it had formed a spin-off company focused on development of follow-on biologics and that it would have biologic candidates in the clinic within the next two years. The initial candidates likely will be follow-ons of Amgen's Aranesp (darbepoetin alfa) and Neulasta (pegfilgrastim) ("The Pink Sheet" DAILY, Feb. 12, 2007).
U.S. companies like Abraxis and CTI are counting on Congress to approve a pathway for regulatory approval of follow-on biologics in this country sooner rather than later.
In June, the Senate Health, Education, Labor and Pensions Committee approved a follow-on biologics bill ("The Pink Sheet" DAILY, June 27, 2007). But, while the HELP committee sponsors remain committed to including the biosimilars legislation in the final version of the FDA reform bill, which the Senate passed in May, the plan faces challenges in both chambers. Unlike the Senate's legislation, the House version of the bill does not include placeholder language that would allow the insertion of biologics legislation (3"The Pink Sheet" DAILY, May 2, 2007).
- Shirley Haley
This article is reprinted from "The Pink Sheet" DAILY – July 20, 2007
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