Alvotech wins FDA for Humira biosimilar process (ALVO:NASDAQ)

Alvotech announced FDA approval for a process that more than doubles Simlandi drug substance output per batch at its Reykjavik facility. The approval follows a prior clearance for U.S. market production. Simlandi is Alvotech's biosimilar to AbbVie's Humira, with Teva as its U.S. commercial partner.

Alvotech's shares rose 8% to $5.41 after the FDA approved a new manufacturing process for Simlandi, its biosimilar to Humira. The process doubles drug output per batch. The stock is down 37% over the past year.

Alvotech (NASDAQ: ALVO, STO: ALVO) received FDA approval for its upgraded manufacturing process, doubling SIMLANDI drug substance output per batch. The company's shares rose 7.19% in Stockholm. Alvotech reported $142.8M in cash at June 30, with no estimate on margin changes from the new process. Teva (NYSE: TEVA) handles U.S. commercialization of SIMLANDI.

Alvotech (ALVO) stock rose 7% in pre-market trading after FDA approved its new manufacturing process for SIMLANDI, a biosimilar to Humira. The approval allows the company to double drug substance output per batch, freeing up capacity for other products. This follows another FDA approval in October. The S&P 500 and NASDAQ were down slightly, indicating the move was driven by company-specific news. Analysts have a 'Moderate Buy' consensus with an average price target above current levels.

Alvotech (ALVO) received FDA approval for a new manufacturing process for its SIMLANDI biosimilar, doubling production per batch. The upgrade supports growing demand and may free capacity for other products. ALVO stock rose 6.96% in pre-market trading.

Alvotech's shares rose 6% premarket after the FDA approved a new manufacturing process for Simlandi, its biosimilar to Humira. The new process, Process 2.0, doubles drug output per batch. The company says this increases capacity for other products and meets growing demand. Alvotech has five approved biosimilars marketed globally.