The U.S. Food and Drug Administration on Tuesday approved Novartis' biosimilar drug Erelzi.
Erelzi was developed by Sandoz — a division of Switzerland-based Novartis — and is intended to treat a variety of inflammation conditions, including rheumatoid arthritis and plaque psoriasis.
The FDA approved the drug as a biosimilar version of Amgen's arthritis drug Enbrel. The approval was based on comprehensive data proving Erelzi was highly similar to Enbrel and achieved the same efficacy and safety levels. Erelzi was approved for all indications listed on Enbrel's product label.
"We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system," said Carol Lynch, global head of biopharmaceuticals for Germany-based Sandoz.
Sandoz has developed two of the three FDA approved biosimilars currently on the market. The drugmaker said it is committed to launching Erelzi in the U.S. as soon as possible.
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