Policy

Adalimumab Biosimilars Show Similar Outcomes in Psoriasis After Nonmedical Switch

March 26th 2025

By Skylar Jeremias

Switching between adalimumab products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

Smart Tendering Policies Unlock Greater Biosimilar Savings

March 20th 2025

By Skylar Jeremias

Article

Tendering emerged as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, while price-linked discounts and prescribing quotas have shown mixed or uncertain results.

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.

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).

Robert F. Kennedy Jr Confirmed as HHS Secretary, Nearly Along Party Lines

February 13th 2025

By Christina Mattina

Article

The Senate voted 52-48 to confirm Robert F. Kennedy Jr as secretary of HHS, setting up the vaccine skeptic to carry out major changes in pursuit of his Make America Healthy Again agenda.

CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets

February 6th 2025

By Skylar Jeremias

Article

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.