Infographic: Changes to BsUFA Under FDARA

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).