The FDA accepted the biologics license applications (BLA) for AVT05, Alvotech’s and Teva Pharmaceuticals’ proposed biosimilar to golimumab (Simponi and Simponi Aria), which treats inflammatory ...

This marks the first U.S. BLA acceptance for a golimumab biosimilar, an anti-TNF therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The FDA review is expected to ...