FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone ...

Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic ...

Biologics approved by the Food and Drug Administration (FDA) for managing ulcerative colitis include: Anti-TNF agents, such as Humira (adalimumab), Simponi (golimumab), Remicade (infliximab ...

Simponi, J&J's second biologic to gain approval ... The current clinical pipeline of biologic drugs includes 240 mAbs and 120 proteins in various other categories, including alternative scaffolds ...