FDA approves Sandoz's biosimilar for Humira

FDA approval of generic pharmaceutical maker Sandoz's Hyrimoz injection, a biosimilar for Humira, has the potential to "to expand access for millions," according to a March 21 news release.

The citrate-free high-concentration formulation injection has been approved to treat a myriad of arthritis conditions as well as ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis.

"The FDA approval of Hyrimoz HCF builds on the already approved and well-established Sandoz global biosimilar portfolio in immunology," the news release states. "When it launches, Hyrimoz HCF will represent the first launch of a Sandoz biosimilar in the U.S. market in this specific disease space."

Hyrimoz HCF met all objectives and showed similar safety levels, pharmacokinetics and immunogenicity as the already FDA-approved adalimumab 50 mg/mL to which it was compared.

As a result of the FDA's approval, Sandoz plans to launch Hyrimoz for availability in the U.S. beginning July 1.

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