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Novartis biosimilars succeed in phase 3 rheumatoid arthritis trials


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Novartis biosimilars succeed in phase 3 rheumatoid arthritis trials

Novartis AG's Sandoz unit said Zessly and Erelzi met the main goals of their respective long-term phase 3 trials in patients with rheumatoid arthritis.

Results from the studies support previous finding that biosimilars Zessly and Erelzi matched their respective reference medicines in terms of safety, effectiveness and quality, the company said.

Further, results showed that switching to the biosimilar from the reference medicine had no effect on safety, efficacy or immunogenicity — the ability of a drug to provoke an immune response.

Zessly is the Swiss drugmaker's biosimilar version of Johnson & Johnson's best-selling drug Remicade. Both drugs are known as infliximab.

Erelzi is a biosimilar of Amgen Inc.'s Enbrel, another blockbuster rheumatoid arthritis, or RA, medicine. Both drugs are also known as etanercept.

The 54-week trial for Zessly, called Reflections B537-02, enrolled 650 RA patients who did not adequately respond to the antirheumatic drug methotrexate. Patients received either Zessly or Remicade combined with methotrexate, and both groups reported at least a 20% improvement in RA symptoms after 14 weeks. Also, no clinically meaningful difference was observed between the treatment groups from 30 to 54 weeks, even after re-randomizing patients.

In the 48-week trial, called Equira, Erelzi did not impact treatment as certain patients switched to it from Enbrel. The study enrolled 376 RA patients who had comparable responses in terms of safety and efficacy, both at 24 weeks and 48 weeks.

"It is our hope that these studies will help healthcare providers and patients have confidence that switching to Zessly or Erelzi will continue to deliver the benefits they are receiving from their existing treatment," said Mark Levick, global head of development, biopharmaceuticals for Novartis unit Sandoz.

Sandoz acquired the European Economic Area rights to Zessly from Pfizer Inc. Under the 2016 agreement, Sandoz can develop, manufacture and market infliximab in the 28 EU countries plus Norway, Iceland and Liechtenstein.