Boehringer Ingelheim Limbering Up With Humira Biosimilar

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 hoping to capture a slice of its pie. Most advanced is Amgen Inc., which has already won regulatory approval for Amjevita/Amgevita in the US and EU (in September 2017 and March 2017, respectively). Amgen has not yet launched its product commercially in the US or the EU, and doesn't expect to do so before 2018 because of ongoing patent litigation