Regulatory

Review Calls for Path to Global Harmonization of Biosimilar Development Regulations

March 17th 2025

By Skylar Jeremias

Article

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

FDA Approves First Omalizumab Biosimilar

March 7th 2025

By Skylar Jeremias

Article

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.

From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

March 6th 2025

By Skylar Jeremias

Article

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.

FDA Approves Third Pair of Denosumab Biosimilars

March 4th 2025

By Skylar Jeremias

Article

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.

Biosimilars Regulatory Roundup: February 2025

March 1st 2025

By Rose McNulty

Article

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements

February 25th 2025

By Cameron Santoro

Article

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.

Will the FTC Be More PBM-Friendly Under a Second Trump Administration?

February 23rd 2025

By Skylar Jeremias

Podcast

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.

EC Approves Celltrion Denosumab, Aflibercept Biosimilars

February 20th 2025

By Skylar Jeremias

Article

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).

FDA, EMA Approve Second Pair of Denosumab Biosimilars

February 17th 2025

By Skylar Jeremias

Article

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.

FDA Approves First Insulin Aspart Biosimilar

February 17th 2025

By Skylar Jeremias

Article

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.