Dr. Reddy's Laboratories, an integrated global pharmaceutical company, and Merck Serono, a division of Merck, have formed a partnership 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. It will also expand on Dr. Reddy's presence in the biosimilar space—having launched four biosimilars to date—in select emerging markets and enables participation globally.
"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,” said G. V. Prasad, vice-chairman and CEO of Dr. Reddy's Laboratories. “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."
Stefan Oschmann, CEO of Merck Serono, added, "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.”
The deal structure calls for Merck Serono and Dr. Reddy's to co-develop the molecules included in the agreement. Dr. Reddy's will lead early product development and complete phase I development. Upon completion of phase I, Merck Serono will take over manufacturing of the compounds and will lead phase III development. The agreement is based on full R&D cost sharing.
Merck Serono will undertake commercialization globally, outside the U.S. and 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 from Merck Serono upon commercialization. In the U.S., the parties will co-commercialize the products on a profit-sharing basis.
