The Top 5 Biosimilar Articles for the Week of August 25

August 29, 2025

Here are the top 5 biosimilar articles for the week of August 25, 2025.

Alvotech Reports Record-Breaking First Half of 2025 Amid Strong Biosimilar Sales

August 27, 2025

Canadian RWE Shows Comparable Outcomes Between Etanercept Biosimilars, Originator

August 26, 2025

Biosimilar Romiplostim Shows Equivalence to Reference Product for Chronic ITP

August 25, 2025

The Top 5 Biosimilar Articles for the Week of August 18

August 22, 2025

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.

No IBD Activity Changes Following Switch From Biosimilar to Originator Infliximab

March 3rd 2025

By Deana Ferreri, PhD

Article

A prospective cohort study found that switching back from the biosimilar SB2 to the reference infliximab did not affect clinical disease activity or safety in inflammatory bowel disease (IBD).

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.

The Top 5 Biosimilar Articles for the Week of February 24

February 28th 2025

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of February 24, 2025.

Bevacizumab Biosimilars Show Similar Efficacy, Safety in NSCLC

February 27th 2025

By Cameron Santoro

Article

Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin.

Adalimumab Biosimilar Switching Policy Shows Long-Term Success in IBD

February 26th 2025

By Skylar Jeremias

Article

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.

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.