European Commission Authorizes Sandoz's Infliximab Biosimilar

Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.

The approval was based on a review of the data that confirmed the infliximab biosimilar was equivalent to the reference product in terms of safety and efficacy. The data included a phase 3 confirmatory study in rheumatoid arthritis, REFLECTIONS B537-02. The study met its primary endpoint of achieving the American College of Rheumatology’s criteria for a 20% improvement (ACR20) response at week 14.

On the strength of the trial results, the biosimilar was authorized for use in all indications of the reference medicine: rheumatoid arthritis, adult Crohn’s disease, pediatric Crohn’s disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

“Biosimilars, such as Zessly, help to address a significant unmet need for earlier patient access to biologic medicines and are at the heart of our Sandoz commitment to improving and extending lives,” said Richard Francis, CEO of Sandoz, in a statement.

Sandoz currently has 3 other biosimilars at various stages of development within its pipeline, including:

• GP2017, a proposed adalimumab biosimilar, was filed with EU regulatory agencies in May 2017, as well as with the FDA in January 2018.
• GP2013, a proposed rituximab biosimilar, received EU approval in June 2017. The drug received a Complete Response Letter (CRL) from the FDA earlier this month, prompting Sandoz to say that it “remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.”
• LA-EP2006, a proposed pegfilgrastim biosimilar, was filed with EU regulatory agencies in October 2017. Sandoz plans to resubmit the biosimilar for FDA approval by 2019, after receiving a CRL in 2016.

Zessly’s EC approval makes it the third biosimilar from Sandoz in the past 12 months to be approved, and the sixth approved biosimilar for the company overall.