Dr. Reddy’s Laboratories and Merck Serono (MS) have entered a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers development, manufacturing and commercialization of the compounds globally.
Dr. Reddy’s will lead early product development through Phase I; MS will take over manufacturing of the compounds and will lead Phase III development. Both companies will share R&D costs. MS will undertake commercialization globally and outside the U.S. with the exception of select emerging markets, which will be co-exclusive or where Dr. Reddy’s maintains exclusive rights. Dr. Reddy’s will receive royalty payments upon commercialization. In the U.S., the parties will co-commercialize the products on a profit-sharing basis.
G. V. Prasad, vice chairman and chief executive officer 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.”
“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,” added Stefan Oschmann, chief executive officer of MS. “Sharing know-how, risks and rewards is the right approach to enter the emergent biosimilars market and will be a win-win for both parties. It further strengthens Merck Serono’s promise to live science and transform lives, by increasing access to quality medicines for patients, physicians and payers.”