Alvotech's SIMLANDI Biosimilar Wins FDA Approval for New Manufacturing Process; ALVO Rises

Alvotech (ALVO) said the U.S. FDA approved a new manufacturing process for SIMLANDI (adalimumab-ryvk), its Humira biosimilar, enabling production under an upgraded process at its Reykjavik, Iceland facility. The agency cleared "Process 2.0" for making adalimumab drug substance in the company's DSM2 production suite. The method more than doubles drug substance output per batch without expanding upstream manufacturing scale, Alvotech said, and demonstrated comparability on quality, safety and efficacy. The efficiency gain is expected to let Alvotech produce the same quantity in fewer batches, potentially freeing capacity for other biosimilars. The approval follows a recent FDA authorization of additional manufacturing capacity in Reykjavik and is meant to support growing demand. ALVO closed Monday's trading at $5.03, up 0.60%, and was at $5.38 pre-market, up 6.96%. Shares have traded between $2.94 and $8.74 over the past year.