Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply

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 (ALVO) shares rose after the FDA approved a new manufacturing process for Simlandi, a biosimilar of AbbVie's (ABBV) Humira, marketed with Teva (TEVA).

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.