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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Breaking Down Biosimilar Barriers: Payer and PBM Policies

November 13th 2024

By Skylar Jeremias

Article

Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.

Overcoming Challenges to Improve Access and Reduce Costs

November 12th 2024

By Skylar Jeremias

Article

Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.

Breaking Down Biosimilar Barriers: The Patent System

November 11th 2024

By Skylar Jeremias

Article

Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.

How Strategic IDNs Boost Biosimilar Adoption

November 10th 2024

By Skylar Jeremias

Video

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses how integrated delivery networks (IDNs) can help drive biosimilar adoption.

Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD

November 9th 2024

By Deana Ferreri, PhD

Article

A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.

The Top 5 Biosimilar Articles for the Week of November 4

November 8th 2024

By Skylar Jeremias

Video

Here are the top 5 biosimilar articles for the week of November 4, 2024.

Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

November 7th 2024

By Skylar Jeremias

Article

For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

Celltrion Sets Sights on 2030 With Expanded Biosimilar Portfolio, Market Reach

November 6th 2024

By Skylar Jeremias

Article

Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with robust sales growth driven by core biosimilars and new launches like subcutaneous infliximab.

Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data

November 5th 2024

By Skylar Jeremias

Article

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?

November 4th 2024

By Sarfaraz K. Niazi, PhD

Article

The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.