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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

August 21st 2024

By Skylar Jeremias

Article

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

Biosimilar CT-P42 Demonstrates Equivalence to Aflibercept for DME

August 20th 2024

By Cameron Santoro

Article

Biosimilar CT-P42 demonstrated comparable efficacy, safety, and tolerability to reference aflibercept in treating diabetic macular edema (DME).

CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel

August 19th 2024

By Skylar Jeremias

Article

CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.

Patent Dance Insights: A Q&A on Reducing Legal Battles in the Biosimilar Landscape

August 18th 2024

By Cameron Santoro

Article

In an interview, Ha Kung Wong, an intellectual property attorney, explained that the Biologics Price Competition and Innovation Act of 2009 provides a structured but optional "patent dance" for biosimilars, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.

The Top 5 Biosimilar Articles for the Week of August 12

August 16th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of August 12, 2024.

No Differences in Long-Term Drug Survival Between Biosimilar, Originator TNF Inhibitors

August 15th 2024

By Skylar Jeremias

Article

An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found no significant differences in survival or discontinuation rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.

Formycon Reports €26.9 Million Revenue for First Half 2024, Driven by Biosimilars

August 14th 2024

By Skylar Jeremias

Article

Formycon's first half 2024 revenue was €26.9 million, boosted by its ranibizumab biosimilar sales but down from last year due to fewer upfront payments and deferred success payments.

FDA Approves Biosimilar Enzeevu for Eye Conditions

August 12th 2024

By Skylar Jeremias

Article

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

BioRationality: Bill to Remove Double Patenting That Harms Biosimilars Heads to the House

August 12th 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, argues that the S-150 bill, also known as the "Affordable Prescriptions for Patients Act of 2023," aims to reduce drug prices by addressing anti-competitive practices, such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market.

Bridging Clinical Practice, Health Economics for Improved Patient Access

August 11th 2024

By Cameron Santoro

Video

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, focused on the cost savings generated by biosimilars and how crucial reinvesting those savings into broader patient access to care is. This approach has the potential to improve health care equity and expand treatment options for patients.