India, Jan. 27 -- Alvotech (ALVO), a biotech company, and Teva Pharmaceutical Industries Limited (TEVA), a pharmaceutical company, on Monday, announced that the FDA has accepted for review the Biologics License Application for AVT05.
AVT05 is a biosimilar candidate to Johnson & Johnson's (JNJ) Simponi and Simponi Aria, also known by their generic name, golimumab, which are approved to treat a variety of inflammatory conditions.
This marks the first U.S. BLA filing for a biosimilar to Simponi/Simponi Aria, with the FDA review expected to be completed by the fourth quarter of 2025.
The combined global sales of Simponi/Simponi Aria for the nine months ended Sep.30, 2024, were $1.61 billion compared to $1.69 billion in the year-ago period.
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