BI Announces Positive Phase 3 Results for Its Biosimilar Adalimumab

On Wednesday, Boehringer Ingelheim (BI) announced results from a phase 3 trial of its adalimumab biosimilar candidate, BI 695501. The study’s results showed that BI 695501 and AbbVie’s branded adalimumab, Humira, have similar clinical efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis (RA).

In the study, 645 patients, aged 18 to 80, with moderate to severe RA and on stable treatment with methotrexate were assessed. The patients were randomized to receive either the reference adalimumab or the biosimilar product at 40 gm every 2 weeks over a period of 48 weeks.

The study met its 2 primary endpoints, which measured 12- and 24-week ACR20 improvement, or the American College of Rheumatology 20% improvement in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity, and acute phase reactant. Additional data from the study demonstrate pharmacokinetic similarity of the biosimilar’s presentation as either a pre-filled syringe or auto-injector.

Karen Kissel, MD, head of Global Medical Affairs Biosimilars at BI, said, “The result that [BI 695501] delivers the same clinical benefits and safety profile as Humira is great news for patients and physicians. If approved by regulatory authorities, it will increase the treatment options for patients with autoimmune diseases, while contributing to the long-term sustainability of healthcare systems.”

The manufacturer has indicated that 24-week results from the study will be presented at the Annual European Congress of Rheumatology, convened this week in Madrid, Spain; 1-year results will be presented at a future medical congress.

BI’s results only add to AbbVie’s woes; in May, the US Patent Trial and Appeal Board ruled against AbbVie, invalidating a dosing patent for Humira in the treatment of RA. AbbVie, which relies on Humira for 63% of its annual sales (ammounting to $16.08 billion in 2016 alone), continues to hold 3 formulation patents for the drug, but the board’s decision cleared the way for biosimilars manufacturers to move forward with their products. In addition to BI’s biosimilar, AbbVie also faces challenges from Coherus, which is developing a biosimilar adalimumab of its own.