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Samsung completes hat-trick of big biosimilar approvals

Published on 25/08/17 at 09:32am

Samsung Bioepis has announced that it, alongside its partner Biogen, has secured European Commission approval for its biosimilar version of Humira. The biosimilar, which will be named Imraldi, will aim to take a substantial chunk in the future of the $16 billion in sales that Humira is expected to reap this year.

The approval for its Humira biosimilar adds to its previous marketing approval for Renflexis, a biosimilar of J&J’s Remicade and BBenepali, a biosimilars of Amgen’s Enbrel.

Imraldi is not the first biosimilar to receive approval from the EC for Humira, after Amgen fought back against biosimilars of its own products by receiving approval for two versions of the drug at the beginning of this year. Both Amgen and Samsung are expected hold back from an ‘at risk’ launch in 2017.

Imraldi, and Amgen’s biosimilars, are not expected to reach the European market until late in 2018 due to the patent protection that AbbVie holds on its biologic.

“We are proud to become the industry’s first to obtain European approval for a third TNF inhibitor. This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost,” said Christopher Hansung Ko, President and CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”

At present, Samsung has raced into the lead in the biosimilars market, in terms of achieving biosimilar approvals to big name, blockbuster drugs. The company will be hoping to use the eventual profits from these products to help finance its recent move into looking to develop original medicines. Earlier this week, Samsung announced that it will collaborate with Takeda to discover its own medicines.

Ben Hargreaves

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