07.06.2012 - German Merck Serono and India’s Dr. Reddy’s will co-develop copycat cancer antibody drugs that are losing patent protection.
Darmstadt/Hyberabad – German Merck has made its first step into the emerging biosimilars market while it restructures its business to cope with expected revenue losses for some of its biggest selling pharmaceutical products. On 6 June, Merck KGaA and Dr. Reddy’s Laboratories Ltd. announced plans to co-develop a portfolio of biosimilar monoclonal antibodies (mAbs) in oncology. With the deal, Merck Serono, whose dual Geneva-based headquarters is to be shut down due to restructuring, expands its market presence to emerging markets. Dr. Reddy’s can benefit from Merck’s access to the European and US market and the company’s know-how in antibody development.
According to the terms of the agreement, the companies will share their expertises to bring new cheaper formulations of approved antibodies to the market, which have lost patent protection. The Indian generic drug maker, who markets already four biosimilars in India and other emerging markets, brings in its expertise in making biosimilar versions of originator drugs and will lead early product development including Phase I studies. Merck-Serono, the biotech arm of German Merck KGaA, will contribute its know-how in developing, manufacturing, and commercialising biopharmaceuticals and will take responsibility for manufacturing and late clinical development. Commercially, Merck will hold the rights to market any co-developed in all markets outside the US with the exception of several unspecified emerging markets. In the US, where rules for biosimilar market approval are expected to be established this year, both Merck and Dr Reddy’s will co-market co-developed mAbs and will share profits. Dr Reddy’s will receive royalty payments from Merck. The companies said they will fully share R&D costs.
Just recently, the world’s largest antibody contract manufacturing firm Boehringer Ingelheim announced to step into the biosimilar field. All major pharma players have already established biosimilar pipelines, because the copycat versions of antibody blockbusters such as Herceptin, Mabthera can be developed 30% cheaper than the originators. Experts say, however, that market uptake of biosimilars will depend on acceptance of the copycat drugs in the US.
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