Partners Alvotech and Teva announced that the FDA has accepted their 351(k) application for AVT05, a biosimilar candidate to compete with the reference product Simponi. Golimumab is a TNF-alpha inhibiting antibody, and the reference manufacturer is Johnson & Johnson. This first golimumab biosimilar drug application covers both the standard Simponi and Simponi Aria forms, which … Continue reading First Golimumab Biosimilar Application Accepted by FDA