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news.Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have collaborated to develop commercial biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs).
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The deal, which is based on full R&D cost sharing, includes co-development, manufacturing and commercialization of the biosimilar compounds.
Dr. Reddy’s will carry out early product development and complete Phase I development, where as Merck Serono will take up the manufacturing activities of the compounds and will lead Phase III development.
Dr. Reddy’s Laboratories vice-chairman and CEO GV Prasad said biosimilars is an important area of future growth and the products gives the opportunity to provide affordable 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," Prasad added.
Merck Serono is responsible for the commercialization, outside the US and with the exception of select emerging markets which will be co-exclusive or where Dr. Reddy’s maintains exclusive rights.
Merck Serono will make royalty payments to Dr. Reddy’s upon commercialization. The companies will co-commercialize the products on a profit-sharing basis in the US. Additional terms of the deal were not disclosed.
Merck Serono chief executive officer Stefan Oschmann said, "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."