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FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024


Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product.

The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs.

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