EMA Accepts Regulatory Review of Proposed Biosimilars to Humira, Remicade

The European Medicines Agency (EMA) accepted Marketing Authorization Applications for the regulatory review of proposed biosimilars for adalimumab and infliximab.

Sandoz is seeking approval of the biosimilars for use in all indications of their reference medications Humira and Remicade, according to a press release.

“Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited,” Mark Levick, MD, PhD, Global Head of Development, Biopharmaceuticals, Sandoz, said in the release. “The EMA’s acceptance of our regulatory submission for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline.”

Included in the EMA submissions were comprehensive data packages that demonstrated biosimilarity to their respective reference medicines in terms of safety, efficacy, and quality.

Clinical data from pharmacokinetic studies and a phase 3 confirmatory safety and efficacy study in patients with moderate-to-severe chronic plaque psoriasis were included in the biosimilar adalimumab submission.

The biosimilar infliximab submission included clinical data from the PK study and phase 3 confirmatory safety and efficacy study in rheumatoid arthritis, according to the release.

These regulatory submissions follow soon after 2 positive CHMP opinions for Sandoz biosimilars etanercept and rituximab.