Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

February 03, 2026

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Q&A With Chelsee Jensen, PharmD: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026

February 02, 2026

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

January 28, 2026

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

January 27, 2026

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

January 26, 2026

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.

3 Ustekinumab Biosimilars Launch on US Market

February 25th 2025

By Skylar Jeremias

Article

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.

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.

Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar

February 22nd 2025

By Deana Ferreri, PhD

Article

A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.

The Top 5 Biosimilar Articles for the Week of February 17

February 21st 2025

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of February 17, 2025.

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.

Teriparatide Biosimilar Shows Comparable Efficacy to Reference Drug in Postmenopausal Osteoporosis

February 17th 2025

By Cameron Santoro

Article

Researchers treated postmenopausal women with osteoporosis with teriparatide biosimilar RGB-10, which improved their bone health measures and reduced fracture risk comparably to reference teriparatide.

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.

BioRationality: A Socratic Analysis of IQVIA Report on Biosimilars

February 17th 2025

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, gives his opinion on how the recent IQVIA report “Assessing the Biosimilar Void in the US” could be improved for the future.