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Boehringer Ingelheim’s new adalimumab biosimilar accepted for regulatory review
Boehringer Ingelheim has announced that its new biosimilar version of the anti-TNF therapy Humira has been accepted for regulatory review.
The European Medicines Agency and the US Food and Drug Administration have accepted the adalimumab biosimilar candidate BI 695501 for assessment as a treatment for multiple chronic inflammatory diseases.
Humira is approved in many countries for the treatment of conditions such as rheumatoid arthritis, inflammatory bowel disease and psoriasis, which collectively affect five to ten percent of the world population.
Data from a phase III study for BI 695501 in patients with active rheumatoid arthritis were announced in October 2016 and have demonstrated the strong potential this new biosimilar provides.
Ivan Blanarik, senior vice-president and head of the biosimilar therapeutic area at Boehringer Ingelheim, said: "We believe that if approved, BI 695501 can provide a valuable treatment option for the people affected by inflammatory diseases in the US and Europe."
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