06/11/2012 | Editor: Dominik Stephan
German pharma giant Merck and generics specialist Dr. Reddy of India have come together to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.
Hyderabad/Indai – G. V. Prasad, Vice-Chairman and CEO of Dr. Reddy’s Laboratories said, "We strongly believe that biosimilars is an important area of future growth and these products give us the opportunity to provide affordable and innovative medicines to patients across the globe. With the recent EMA and FDA guidance on biosimilars, it is clear that any significant player in the field will need strong biologics development, manufacturing and commercialization capabilities. Merck Serono’s and Dr. Reddy’s joint expertise in these fields makes for a powerful global partnership."
This project is Merck's first step into the bisimilar market, company speakers explained. Earlier this year, the company set up a dedicated biosimilars unit that will be based in the Canton of Vaud in Switzerland, where the main biologics manufacturing facilities of the division are located.
“Our expertise in developing, manufacturing and commercializing biopharmaceuticals gives us a clear advantage in the biosimilars field and the partnership with Dr. Reddy’s will bring their first-in-market experience in biosimilars, as well as their expertise in generics and Emerging Markets, to the table,” said Stefan Oschmann, Executive Board Member of Merck and head of the Merck Serono division.
The deal structure calls for Merck and Dr. Reddy’s to co-develop the molecules included in the agreement. While Dr. Reddy’s will lead the early product development and complete Phase I development, Merck Serono will take over upon completion of Phase I. The German company will then conduct the manufacturing of the compounds and lead Phase III development. R&D cost will be shared in equal parts by both partners, officials stated.
India's biotechnology advances – especially biosimilars profited from strategic cooperations and alliances: A market report by Ernst & Young ('Beyond Borders – Global Biotechnology Report') sees great potentials for India's biotechnology industry. Only recently, the country's biotech market reached a record turnover of over US $ four billion.
More on international cooperations in India's pharmaceutical industry? See also Business Success in India Depends on the Partner’s Ability to Deliver Quality - Quickly and Efficiently.
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