CHMP Grants Sandoz Positive Opinion for Proposed Infliximab Biosimilar

Novartis division Sandoz announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for the marketing authorization of its biosimilar infliximab.

The positive opinion is based on comprehensive data confirming the biosimilarity of infliximab to the reference product through analytical, preclinical, and clinical data that found the biosimilar matches the reference product in terms of quality, efficacy, and safety. CHMP has recommended the proposed biosimilar for the treatment of all indications of the reference product, including gastroenterology, rheumatology, and dermatology.

“Sandoz is proud to be at the forefront of diversifying the biologics treatment landscape by bringing biosimilar medicines to market for patients living with devastating autoimmune diseases. Today’s positive CHMP opinion marks a strong step forward in our efforts to accelerate patient access to biologics, and specifically infliximab, through our leading portfolio,” said Richard Francis, CEO of Sandoz, in a statement.

In the next step of the biosimilar approval process, the European Commission (EC) will review the CHMP’s positive opinion. The EC has the authority to approve or deny medicines for the European Union. If the EC approves the proposed biosimilar, it will grant a centralized marketing authorization that will be valid in the 28 EU member countries. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow corresponding decisions based on the EC’s recommendation.

Sandoz currently has 5 other biosimilars on the European market, including somatropin (sold as Omnitrope), epoetin alfa (sold as Binocrit), filgrastim (sold as Zarzio in Europe), etanercept (sold as Erelzi), and rituximab (sold as Rixathon). In addition, it has another 3 biosimilars in its pipeline: LA-EP2006, a proposed pegfilgrastim biosimilar for the treatment of chemotherapy induced neutropenia; GP2013, a proposed rituximab biosimilar currently approved in the EU and pending an FDA decision for the treatment of certain blood cancers and inflammatory diseases; and GP2017, a proposed adalimumab biosimilar to potentially treat autoimmune diseases, such as rheumatoid arthritis and psoriasis.