Boehringer Ingelheim Throws Its Humira Biosimilar Hat Into The Ring

Boehringer Ingelheim is poised to submit marketing applications in the US and Europe for its biosimilar adalimumab after it showed equivalent safety and efficacy to Humira in a pivotal study.

Boehringer Ingelheim GMBH is lining up for its chance to introduce a biosimilar version of Humira, after reporting top-line pivotal Phase III data showing that its BI 695501 has a similar efficacy and safety profile to AbbVie Inc.’s top-selling product.

The development comes as Amgen Inc. – potentially the first pretender to Humira’s US throne with its recently approved Amjevita – is braced for questioning at its third quarter results presentation on Oct. 27 on its launch tactics for the product. Specifically, whether it will launch the product “at risk” before patent disputes have been settled, as Pfizer Inc. has decided to do with its biosimilar version of Johnson & Johnson’s anti-TNF Remicade (infliximab), Inflectra

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