Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

October 15, 2024

Regeneron appeals legal decision after judge refuses to block aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM) becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Blue Shield of California Lowers Humira Biosimilar Costs, Challenges PBM Pricing

October 15, 2024

IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics

October 14, 2024

From Skepticism to Success: Insights Into Biosimilar Market Acceptance

October 13, 2024

Pharmacokinetic Modeling Proposes Cost-Effective Dosing for Adalimumab, Etanercept Biosimilars

October 12, 2024

Featured Content

FDA Approves Imuldosa, a Biosimilar to Stelara

October 11th 2024

By Skylar Jeremias

Article

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share

October 11th 2024

By Skylar Jeremias

Article

Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.

The Top 5 Biosimilar Articles for the Week of October 7

October 11th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of October 7, 2024.

Sandoz Report: A Unified Approach to Overcoming Drug Shortages

October 10th 2024

By Skylar Jeremias

Article

A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.

Duke Publishes Recommendations for Developing CGT Biosimilars

October 9th 2024

By Skylar Jeremias

Article

Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.

Biosimilar Rituximab Safe, Effective for SLE After Switching

October 8th 2024

By Cameron Santoro

Article

A study found that switching from rituximab to biosimilar CT-P10 is safe and effective for patients with systemic lupus erythematosus (SLE).

BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US

October 7th 2024

By Sarfaraz K. Niazi, PhD

Article

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.

Biosimilars Policy Roundup for September 2024—Podcast Edition

October 6th 2024

By Skylar Jeremias

Podcast

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD

October 5th 2024

By Deana Ferreri, PhD

Article

A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.

The Top 5 Biosimilar Articles for the Week of September 30

October 4th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of September 30, 2024.