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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Biosimilars Gastroenterology Roundup: November 2024

November 30th 2024

By Skylar Jeremias

Article

In November 2024, Skyrizi surpassed Humira as AbbVie's top seller; calls for PBM transparency and biosimilar access reforms grew; Celltrion expanded its portfolio; and Global Biosimilars Week focused on improving affordability and equity.

The Top 5 Biosimilar Articles for the Week of November 25

November 29th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of November 25, 2024.

Biosimilar Approval and Uptake Impacted by Global Regulatory Frameworks

November 28th 2024

By Cameron Santoro

Article

Regulatory policies influence the availability of affordable biosimilars, with varying impacts across different jurisdictions.

Retrospective Study Shows Bevacizumab Biosimilar Efficacy in NSCLC

November 27th 2024

By Skylar Jeremias

Article

Bevacizumab biosimilars have the potential to expand access and reduce costs without compromising patient outcomes in advanced non–small cell lung cancer (NSCLC)

Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy

November 27th 2024

By Skylar Jeremias

Article

The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.

Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone

November 26th 2024

By Ashling Wahner

Article

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.

Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment

November 26th 2024

By Skylar Jeremias

Article

The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars

November 25th 2024

By Skylar Jeremias

Article

Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.

How Early Adopters Are Shaping the Future of Biosimilars

November 24th 2024

By Skylar Jeremias

Article

Early adopters of biosimilars have paved the way for broader acceptance by sharing real-world success strategies, overcoming initial resistance, and highlighting best practices for integration and cost savings.

Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy

November 23rd 2024

By Deana Ferreri, PhD

Article

In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.