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Boehringer claims EU okay for Humira biosimilar

But won’t launch before expiration of the respective SPC for adalimumab in October 2018

BI

Boehringer Ingelheim has picked up its first EU approval for a biosimilar drug, getting a green light from the EMA for its version of AbbVie’s blockbuster immunotherapy Humira.

The biosimilar - called Cyltezo - has been approved for all of the indications held by Humira (adalimumab), covering a range of chronic inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis and psoriasis.

Earlier this month Boehringer reported the results of the VOLTAIRE-RA in patients with moderate-to-severe rheumatoid arthritis, showing that Cyltezo was equivalent to $16bn-a-year Humira - the world’s biggest-selling drug - with no clinically meaningful difference in efficacy, safety and immunogenicity.

The approval does not mean that Boehringer will launch its biosimilar straight away. Already locked in a legal tussle with AbbVie over intellectual property for adalimumab in the US, the German drugmaker has already indicated it does not intend to launch the biosimilar in Europe until October 2018 - after AbbVie’s patent protection for the drug expires.

Cyltezo was approved by the FDA in August, and a launch there will depend on the outcome of litigation. AbbVie recently agreed a deal with another Humira biosimilar developer - Amgen - that will delay the introduction of its Amgevita biosimilar until 2023 in the US.

Nevertheless, the approval “marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases”, said Boehringer’s head of biosimilars Ivan Blanarik.

“We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”

Amgen’s biosimilar has already been approved in the EU, while Samsung Bioepis has also won EU approval for its Imraldi biosimilar of Humira. Additional competition could come ahead of the October 2018 launch from Sandoz, which has also filed for approval of its version of adalimumab with the EMA but has yet to do so in the US because of manufacturing capacity constraints.

14th November 2017

From: Regulatory

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