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Boehringer Ingelheim Limbering Up With Humira Biosimilar

 
• By Eleanor Malone

Presenting equivalence data at EULAR for its biosimilar version of the world's best-selling drug, Humira, Boehringer Ingelheim is optimistic about its position in a crowded field. Karsten Kissel, head of global medical affairs biosimilars for the German group, spoke to Scrip.

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Boehringer Ingelheim early to gates in crowded field • Source: Shutterstock

Boehringer Ingelheim GMBH has presented pivotal Phase III results for BI 695501, its biosimilar version of AbbVie Inc.'s top-selling anti-TNF drug Humira (adalimumab), at the Annual European Congress of Rheumatology (EULAR) in Madrid, Spain. The results of VOLTAIRE-RA demonstrate clinical equivalence of '501 and Humira, completing the body of evidence needed to prove biosimilarity and earn approval from regulators. The candidate has already been accepted for filing in both the EU and US, but the company is not commenting on its expectations for the timing of approval decisions. In any case, commercial launch is likely to be delayed by AbbVie's patent defenses.

Humira is the world's top-selling drug, generating revenues of $16.5bn for AbbVie in 2016, and there are multiple biosimilar contenders...

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