Dr.Reddy's Laboratories Ltd And Merck KGaA's Merck Serono Announces Collaboration To Develop And Commercialize Biosimilars

Dr.Reddy's Laboratories Ltd and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced 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. 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 US 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 US, the parties will co-commercialize the products on a profit-sharing basis. Additional terms of the deal were not disclosed.