The Merck Serono and Dr. Reddy’s partnership marks the first step by Merck to enter the biosimilar space. The Merck Serono division began exploring the opportunity last year to assess how it could capitalize on its expertise in biopharmaceuticals and its growing presence in key markets including select Emerging Markets.
Earlier this year, it set up a dedicated biosimilars unit that will be based in the Canton of Vaud in Switzerland, where the main biologics manufacturing facilities of the division are located.
“The deal structure calls for Merck and Dr. Reddy’s to co-develop the molecules.”
“Dr. Reddy’s will lead early product development and complete Phase I development.”
“Upon completion of Phase I, the Merck Serono division 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.”
“At the time of commercialization, Dr. Reddy’s will receive royalty payments from Merck Serono.”
“In the US, the parties will co-commercialize the products on a profit-sharing basis.
The move into biosimilars by Merck Serono is a part of the Merck Group’s transformation program, through a diversified business focused on delivering long-term value and growth opportunities.