Dr Reddy`s, Merck Serono sign pact for biosimilars

Updated: Jun 06, 2012, 16:04 PM IST

New Delhi: Dr Reddy`s Laboratories (DRL) today said it has entered into a partnership with Merck Serono to co-develop, manufacture and market a portfolio of biosimilar compounds in oncology.

"The partnership covers co-development, manufacturing and commercialisation of the compounds around the globe, with some specific country exceptions," DRL said in a statement.

Merck Serono is a division of Merck KGaA of Germany. Biosimilars, or follow-on biologics, are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products.

As per the deal structure, 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, Dr Reddy`s said.

The agreement is based on full research and development cost sharing it added.
Merck Serono will undertake commercialisation 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.

The Hyderabad based firm will receive royalty payments from Merck Serono upon commercialisation. In the US, the parties will co-commercialise the products on a profit-sharing basis.

However, the company did not disclose the additional terms of the deal such as the quantum of the royalty to be paid to the domestic firm and the percentage of the profits it will get.

Commenting on the development Dr Reddy`s Vice-Chairman and CEO G V Prasad said: "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".

The Merck Serono and Dr Reddy`s partnership marks the first step by Merck Serono to enter the biosimilar space, Merck Serono said in a statement.

"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," Merck Serono CEO Stefan Oschmann said on the development.