Merck, Hanwha To Develop Enbrel Biosimilar

Merck and Hanwha Chemical Corp. have entered into an exclusive global agreement to develop and commercialize HD203, Hanwha’s biosimilar form of Enbrel. Hanwha, through its Bio Business Unit, and Merck, through a subsidiary, will work to develop and commercialize HD203. Merck will conduct clinical development and will be responsible for manufacturing. Upon marketing approval, Merck will commercialize HD203 globally, except for in Korea and Turkey, where Hanwha retains marketing rights. Financial terms were not disclosed, but Hanwha will receive an upfront payment from Merck and will be eligible for additional milestone payments and royalties on sales.

“This collaboration to develop and commercialize our lead biosimilar candidate with a leading global health care company such as Merck represents a significant event both strategically and financially for Hanwha and underscores the success of our biopharmaceutical strategy,” said K.J. Hong, chief executive officer Hanwha.

“Hanwha has established outstanding biopharmaceutical development capabilities,” said Michael Kamarck, president, Merck BioVentures. “Enbrel is widely considered to be one of the most important biosimilar molecules. This candidate represents a valuable addition to our broad biosimilars portfolio, as we advance our strategy to provide patients with improved access to biologic therapies.”

HD203 is currently being evaluated in Korea in a Phase III trial to evaluate the equivalence in efficacy and safety of HD203 and Enbrel in combination with methotrexate in patients with rheumatoid arthritis.