Novartis Gets Positive EMA Opinion on Biosimilar to J&J’s Remicade

March 29, 2018

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

On March 23, 2018, Sandoz, the generic drug arm of Novartis, announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for marketing authorization of infliximab, a proposed biosimilar to the reference product, Remicade (infliximab), Janssen Biotech’s biologic. Janssen Biotech is a Johnson & Johnson (J&J) company.

Remicade is J&J’s top-selling product with more than $6.3 billion in 2017 sales. Remicade is marketed in Europe by MSD (Merck & Co. in the United States).

The CHMP opinion recommends the proposed Sandoz biosimilar infliximab for treating all indications of the reference product across 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," said Richard Francis, CEO, Sandoz, in a company press release. "[The] positive CHMP opinion marks a strong step forward in our efforts to accelerate patient access to biologics, and specifically infliximab, through our leading portfolio."

The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will review the CHMP's positive opinion. If approved, the EC will grant a centralized marketing authorization that will be valid in the 28 member countries of the EU. Norway, Iceland, and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the EC's recommendation.

This recommendation marks the third CHMP positive opinion granted for a Sandoz biosimilar in 12 months, following Erelzi (etanercept-szzs), referencing Amgen’s Enbrel (etanercept), and Rixathon (biosimilar rituximab), referencing Roche’s MabThera/Rituxan.

Sandoz acquired infliximab (PF-06438179) development, commercialization, and manufacturing rights from Pfizer in February 2016 for the 28 EU countries plus Norway, Iceland, and Liechtenstein. Under the divestment, Pfizer retains commercialization and manufacturing rights to infliximab (PF-06438179) in countries outside the EEA. Sandoz has five marketed biosimilars products and several more major oncology and immunology launches expected globally by 2020.

Source: Novartis