The Top 5 Biosimilar Articles for the Week of June 23

June 27, 2025

Here are the top 5 biosimilar articles for the week of June 23, 2025.

Eye on Pharma: CHMP Aflibercept Decision; Omalizumab Results; Dupilumab Biosimilar Deal

June 26, 2025

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

June 25, 2025

Omalizumab Biosimilar Matches Reference Product in Chronic Spontaneous Urticaria

June 24, 2025

BioRationality: Questioning Experts and Journals Reporting on Biosimilar Bill to Remove Interchangeability

June 23, 2025

How Policy Reforms in PBM Systems Could Change the Adalimumab Market

October 28th 2024

By Skylar Jeremias

Article

Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

Veterans’ Experience With Infliximab Biosimilars for IBD Treatment

October 26th 2024

By Deana Ferreri, PhD

Article

A study of the Veterans Health Administration detailed their experience with infliximab biosimilars in a population of patients with inflammatory bowel disease (IBD) who were naive to infliximab.

Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf

October 25th 2024

By Skylar Jeremias

Article

At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.

The Top 5 Biosimilar Articles for the Week of October 21

October 25th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of October 21, 2024.

FDA and Industry Experts Unpack Biosimilar Device Requirements

October 23rd 2024

By Skylar Jeremias

Article

At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.

Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims

October 23rd 2024

By Skylar Jeremias

Article

At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.

Unifying Standards: The Need for Streamlined Biosimilar Development

October 22nd 2024

By Skylar Jeremias

Article

At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.

GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability

October 22nd 2024

By Skylar Jeremias

Article

At the GRx+Biosims 2024 conference, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got It Covered

October 21st 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing that manufacturer-developed materials aren't needed.

Addressing Hesitance in Biosimilar Adoption

October 20th 2024

By Skylar Jeremias

Video

Sophia Humphreys, PharmD, from Sutter Health explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education.