Dr. Reddy’s and Merck Serono to develop and commercialise biosimilars

Combined expertise and sharing of know-how, risks and rewards aims to deliver on promise of biosimilars

Dr. Reddy’s Laboratories and Merck Serono, a division of Merck KGaA, have entered into 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 commercialisation of the compounds around the globe, with some specific country exceptions.

Dr. Reddy’s has launched four biosimilars molecules to date, and the partnership with Merck Serono expands on the company’s presence in the biosimilar space in select emerging markets and enables participation globally.

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 commercialisation globally, outside the US and with the exception of select emerging markets that will be co-exclusive or where Dr. Reddy’s maintains exclusive rights. Dr. Reddy’s will receive royalty payments from Merck Serono upon commercialisation. In the US, the parties will co-commercialise the products on a profit-sharing basis. Additional terms of the deal were not disclosed.

‘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 commercialisation 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 commercialising 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, ceo of Merck Serono. ‘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.’

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Merck KGaA (more information, website)

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