Merck, Hanwha to develop Enbrel biosimilar

WHITEHOUSE STATION, N.J. — Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.

Merck, which operates outside the United States and Canada as MSD to avoid confusion with Germany-based Merck KGaA, announced Monday a collaboration with Seoul, South Korea-based Hanwha Chemical to develop and commercialize HD203, a biosimilar version of Enbrel (etanercept), made by Amgen and Pfizer. The drug is used to treat such disorders as rheumatoid arthritis and psoriasis.

Under the agreement, Hanwha’s Bio Business Unit and a Merck subsidiary will work on the biosimilar, developed by Hanwha. Merck will be responsible for clinical development and manufacturing and will commercialize the drug in markets around the world, except Korea and Turkey, where Hanwha has marketing rights. Financial terms were not disclosed, but the companies said they will involve upfront commercial payments and potential milestones and royalties for Hanwha.

“This collaboration to develop and commercialize our lead biosimilar candidate with a leading global healthcare company such as Merck represents a significant event both strategically and financially for Hanwha, and underscores the success of our biopharmaceutical strategy,” Hanwha CEO K.J. Hong said. “We are excited and proud that Hanwha’s biobusiness is now well-positioned to make a major contribution toward providing access to a biosimilar form of one of the world’s leading biologic therapies.”

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