Skylar Jeremias

March 07, 2025

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.

March 06, 2025

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.

March 04, 2025

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.

February 26, 2025

Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.

February 25, 2025

Three ustekinumab biosimilars enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable drugs in the world.

February 23, 2025

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.

February 20, 2025

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).

February 17, 2025

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

February 17, 2025

The FDA approved Merilog (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

February 14, 2025

Although Lantus continues to lead the insulin glargine market globally, the rise of biosimilars like Abasaglar and Semglee has sparked significant price reductions, with some European countries seeing discounts of up to 42.3%.