Boehringer Ingelheim completes enrolment for biosimilar adalimumab trial

Boehringer Ingelheim has completed enrolment for a pivotal phase III trial of BI695501, a new biosimilar version of AbbVie's drug adalimumab.

The phase III clinical trial is a randomised active comparator trial in patients who have been diagnosed with moderate to severe rheumatoid arthritis and are currently being treated with methotrexate.

Each participant is randomised to receive either BI695501 or the original reference product every two weeks for 48 weeks.

This follows the recent publication of results from a phase I trial that demonstrated pharmacokinetic bioequivalence between the biosimilar and the original reference product, which is sold under the brand name Humira.

Dr Sandeep Athalye, vice-president and head of clinical development and medical affairs for biosimilars at Boehringer Ingelheim, said: "Our long-term commitment is to become a global leader in biosimilars, thereby supporting access to biologic medicines around the world."

Boehringer Ingelheim is one of the largest producers of biologic medicines in the world, having developed more than 20 medicines in this category.