Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
Alvotech (ALVO)
Company Research
Source: GlobeNewswire
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of StelaraSELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the production of Stelara REYKJAVIK, Iceland and PARSIPPANY, N.J., April 16, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and
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- U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira® (adalimumab)GlobeNewswire
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ALVO
Sec Filings
- 4/30/24 - Form 6-K
- 4/25/24 - Form 6-K
- 4/19/24 - Form 6-K
- ALVO's page on the SEC website