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news.Merck and Hanwha Chemical have signed an agreement for the development and commercialization of HD203, a biosimilar candidate of Enbrel (etanercept).
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The contract allows Merck, known as MSD outside the US and Canada, to conduct clinical development and manufacture the product.
Merck will also get the rights to commercialize the product across the globe except in Korea and Turkey, following the receiving of marketing approval.
HD203 is currently being evaluated, in Korea, in a randomized double-blind active-controlled parallel group Phase III clinical trial to investigate the equivalence in efficacy and safety of HD203 and Enbrel in combination with methotrexate in patients with rheumatoid arthritis.
Under the terms of the agreement, Merck is responsible to pay upfront payment to Hanwha along with additional payments linked with milestones for technology transfer and regulatory progress.
Hanwha is also eligible to receive tiered royalties on sales from Merck.
Specific financial terms of the agreement were not disclosed.
Merck BioVentures president Michael Kamarck said Enbrel is considered to be one of the important biosimilar molecules.
"This candidate represents a valuable addition to our biosimilars portfolio, as we advance our strategy to provide patients with improved access to biologic therapies," Kamarck said.