Amgen and Pfizer seek deal with Russian non-originator biologicals firm

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Amgen and Pfizer seek deal with Russian non-originator biologicals firm

Home/Pharma News | Posted 30/08/2013 0 Post your comment

Russian biotechnology company Biocad is reported to be attracting offers from US-based Pfizer and biotechnology giant Amgen.

Biocad, which is working on non-originator biologicals of some of the world’s top-selling cancer medicines, is expected to be worth as much as US$1 billion. The company is thought to be seeking funds in order to fund clinical trials for the non-originator biologicals they have in the pipeline.

According to ClinTrials.gov the company is already carrying out phase III clinical trials for three of its non-originator biological candidates, BDC-20 (MabThera), BCD-021 (Avastin) and BCD-022 (Herceptin). The products are non-originator biologicals of Roche’s blockbuster cancer drugs MabThera (rituximab), Avastin (bevacizumab) and Herceptin (trastuzumab).

Biocad is well-positioned in the Russian market, winning many governmental tenders, and making it a lucrative target for companies wanting to enter the market. The only drawback is that Russia, although it has a strong generics market, has yet to develop a regulatory framework for biologicals or non-originator biologicals.

Biocad has already collaborated with Pfizer in the past and in 2012 signed an agreement to produce a drug for haemophilia.

Amgen and Pfizer are not alone in their interest in the company, with the third bidder competing for the company, rumoured to be possibly Roche or generics giant Teva Pharmaceutical Industries.

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related article
Russia to harmonize biologicals regulations

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