FDA approves Simlandi as first high-concentration interchangeable biosimilar to Humira
Icelandic firm Alvotech (Nasdaq: ALVO) and Israel’s Teva Pharmaceutical Industries (NYSE and TASE: TEVA) on Friday announced that the US Food and Drug Administration (FDA) has approved Simlandi (adalimumab-ryvk) injection.
The product is cleared as an interchangeable biosimilar to AbbVie’s blockbuster Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.
Shares of Alvotech gained almost 3% to $16.03 on the news, while those of Teva rose 4% to 4,974 shekels but fell 1.2% to $12.89 in New York trading.
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