The FDA and EMA accept for review BI 695501 (adalimumab biosimilar) as a biosimilar to Humira. - Boehringer

Boehringer Ingelheim announced that BI 695501, its adalimumab biosimilar candidate to Humira, has been accepted for regulatory review by the European Medicines Agency (EMA) and the FDA. Boehringer Ingelheim is seeking approval for BI 695501 as a biosimilar to Humira in the European Union and the United States.

Adalimumab is a monoclonal antibody that blocks TNF-alpha, an important mediator of inflammation in the human body. Adalimumab is approved as a biologic medicine under the brand name Humira in many countries for the treatment of multiple chronic inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. Top-line results from the completed Phase III study for BI 695501 in patients with active rheumatoid arthritis were announced on October 26, 2016.

Comment: Patents for Humira are expected to expire in April 2018 in the EU and in March 2019 in the US, however Abbvie claims that the patents extend to 2022.

Comment:Amgen has FDA approval for its adalimumab biosimilar, Amjevita, but has not launched as it is engaged in a patent infringement case brought by AbbVie which could delay launch for up to three years.