Sandoz gets EU approval for Zessly Biosimilar

Sandoz, part of Swiss drugmaker Novartis, has won approval from the European Commission for its biosimilar Zessly (infliximab). The drug, which is a version of Janssen Biotech’s Remicade, marks Sandoz’s sixth biosimilar approval overall and its third in Europe in the past 12 months.

Zessly blocks the action of tumor necrosis factor (TNF)-alpha in patients with certain autoimmune diseases. The drug is approved for uses including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Richard Francis, CEO of Sandoz, said the approval is a key milestone in bringing the medicine to patients. “Biosimilars such as Zessly help to address a significant unmet need for earlier patient access to biologic medicines,” he commented.

The company bought the development, commercialization and manufacturing rights for infliximab from Pfizer in February 2016 for the EU 28 countries plus Norway, Iceland and Liechtenstein. Pfizer retained commercialization and manufacturing rights for countries elsewhere.

Sandoz said it expects to launch several more major oncology and immunology drugs globally by 2020. In January, it submitted a biosimilar version (adalimumab) of AbbVie’s Humira to the US Food and Drug Administration (FDA) for review. That same month, Sandoz announced a partnership with India biopharma Biocon to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide.

However, Sandoz suffered a setback earlier this month when the FDA rejected its biosimilar version of rituximab, a monoclonal antibody that is marketed in the US by Biogen and in Canada and Europe and by Roche. The company said it stands behind the robust body of evidence in its submission and remains committed to further discussions with the agency.