Merck and Hanwha to develop biosimilar form of Enbrel

Published: 13-Jun-2011

Merck will pay an upfront fee to Hanwha, which is eligible for additional milestone payments


Merck and Hanwha Chemical Corporation of South Korea have signed an agreement for the development and commercialisation of HD203, a biosimilar candidate of Enbrel (etanercept).

Enbrel is used for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

Under the terms of the agreement, Merck, known as MSD outside the US and Canada, will conduct clinical development and handle manufacturing.

After receiving marketing approval, Merck will commercialise the product globally, except in Korea and Turkey, where Hanwha will retain marketing rights.

In return, Hanwha will receive an upfront payment from Merck and will be eligible for additional milestone payments as well as tiered royalties on sales. Reuters said the deal was worth around US$720m.

This collaboration represents a significant event both strategically and financially for Hanwha and underscores the success of our biopharmaceutical strategy, said Hanwha Chemical’s chief executive K J Hong.

‘Enbrel is widely considered to be one of the most important biosimilar molecules,’ added Michael Kamarck, president, Merck BioVentures. ‘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 randomised double-blind active-controlled parallel group Phase III clinical trial to evaluate the equivalence in efficacy and safety of HD203 and Enbrel in combination with methotrexate in patients with rheumatoid arthritis. Clinical trials have yet to be initiated in the US.

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