Settled lawsuit paves way for Humira biosimilar in EU from October

By Staff Reporter

- Last updated on GMT

GettyImages/Ulf Wittrock
GettyImages/Ulf Wittrock
The first Humira (adalimumab) biosimilar could be available in Europe by October after Samsung Bioepis settled a lawsuit with AbbVie.

All pending litigation between Samsung Bioepis and Humira’s originator firm AbbVie has been settled, the South Korean biosimilar developer said yesterday, paving the way for the launch of its adalimumab biosimilar SB5.

The European Commission (EC) approved SB5 under the name Imraldi in August 2017​, and following this announcement it could be launched from October 16 this year.

“We welcome this agreement which clears the way for SB5 in approved markets across the world,”​ said Jaywoo Kim, head of the commercial division at Samsung Bioepis. “The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region,”

Imraldi is not the only biosimilar looking to take a piece of the adalimumab market – last year worth $18.4bn globally ($12.3bn in the US).

Amgen’s Amgevita was the first adalimumab biosimilar to be approved in March 2017​, while Boehringer-Ingelheim’s Cyltezo received EC approval in November 2017​.

A spokesperson from Boehringer-Ingelheim told us it does not intend to launch Cyltezo in the EU before expiration of the respective Supplementary Protection Certificate (SPC) for adalimumab which expires in October 2018. The firm is itself engaged in patent litigation with AbbVie in the US.

Amgen was the first to receive approval for its biosimilar – Amjevita – in the US in 2016​, but will only be able to launch the product from January 31 2023 following a legal settlement with AbbVie in October last year​.

Samsung Bioepis – a joint venture between Samsung Biologics and Biogen – has not announced a regulatory submission in the US so far, but said in a statement when it does, and if successful, it would expect to launch a product from June 2023.

Related topics: Markets & Regulations, Biosimilars

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