Another Humira Biosimilar Accepted for Regulatory Review


Humira is currently approved to treat rheumatoid arthritis, inflammatory bowel disease, and psoriasis.

Boehringer Ingelheim recently announced that the novel biosimilar BI 695501 was accepted for regulatory review by both the European Medicines Agency and the FDA. BI 695501 is a biosimilar candidate vaccine to Humira (adalimumab), according to a press release from the company.

Adalimumab is a monoclonal antibody that inhibits TNF-α, which is critical for inflammation in the body. Currently adalimumab is approved to treat chronic inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis.

These conditions affect 5% to 10% of the world’s population, with 23.5 million individuals in the United States and 36.3 million individuals in Europe diagnosed with these diseases, according to Boehringer.

Positive results from a phase 3 clinical trial in rheumatoid arthritis were previously announced.

In the clinical trial, the researchers found that BI 695501 met the primary and secondary efficacy endpoints. The phase 3 trial included 645 patients with moderate to severe rheumatoid arthritis who were treated with methotrexate.

Study participants were randomized to receive treatment with BI 695501 or Humira every 2 weeks for 48 weeks. The investigators assessed BI 695501 in terms of the proportion of patients meeting the American College of Rheumatology 20 criteria versus Humira. The candidate biosimilar showed efficacy in those measures, and in other efficacy, safety, and immunogenicity parameters, according to Boehringer.

“This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe,” said Sandeep Athalye, MD, vice president and head, Clinical Development and Medical Affairs Biosimilars of Boehringer Ingelheim about the phase 3 results. “With our focus on BI 695501 and other biosimilar candidates, we recognize biosimilars as playing an increasing role in providing patients and doctors with high quality therapeutic options while contributing to the long term sustainability of healthcare systems.”

Boehringer currently has 2 late stage biosimilar monoclonal antibodies in its pipeline. Besides the Humira biosimilar candidate, Boeringer is developing BI 695502, which is a biosimilar candidate for Avastin (bevacizumab), according to the press release.

Pfizer recently announced that their Humira biosimilar candidate vaccine also performed well in clinical trials, although it has not been submitted for regulatory approval. If both vaccines and other Humira biosimilars are approved, this may drive down costs significantly for patients with the indicated conditions.

“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,” said Ivan Blanarik, senior vice president and head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “The acceptance of our first biosimilar regulatory filings by the FDA and EMA is an important milestone towards offering a high-quality treatment choice to patients and physicians while contributing to the sustainability of healthcare systems.”

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