Teva Says The Time Is Right For Two Big Immunology Biosimilar Launches

US market access senior VP Tom Rainey talks to Scrip about the upcoming launches of biosimilar versions of Humira and Stelara.

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Teva remains enthusiastic about biosimilars. • Source: Shutterstock

Teva Pharmaceutical Industries Ltd. is optimistic about two big upcoming biosimilar launches in the US in the immunology space despite market dynamics that have prevented substantial biosimilar uptake. The company is preparing to launch Simlandi (adalimumab-ryvk), a biosimilar version of AbbVie Inc.’s Humira (adalimumab), within weeks and Selarsdi (ustekinumab-aekn), a biosimilar version of Johnson & Johnson’s Stelara (ustekinumab), next year.

Teva’s partner, Alvotech , developed the biosimilars, with Simlandi receiving US Food and Drug Administration approval in February for all of Humira’s indications, including rheumatoid arthritis, plaque psoriasis and ulcerative colitis. (Also see "Alvotech FDA Approval Clears Path To Challenge Humira" - Generics Bulletin, 26 February, 2024.) The FDA approved Selarsdi for Stelara’s dermatology indications, plaque psoriasis and psoriatic arthritis, on 16 April

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