A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

BioRationality: What’s Wrong With the Indian CDSCO Biosimilar Guidelines?

January 7th 2025

By Sarfaraz K. Niazi, PhD

Study Confirms CT-P42 Therapeutic Equivalence to Reference Aflibercept in DME

January 6th 2025

By Skylar Jeremias

The phase 3 trial showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.

Reducing Financial Toxicity in GI Cancer Care Through Biosimilars

January 5th 2025

By Skylar Jeremias

Tiago Biachi, MD, PhD, emphasizes that biosimilars are vital for reducing financial toxicity and ensuring equitable, affordable access to advanced treatments in gastrointestinal (GI) cancer care, while calling for dynamic policies and greater cost awareness among clinicians.

Etanercept and Infliximab Biosimilars Show No Increased Infection Risk, Comparable Safety

January 4th 2025

By Cameron Santoro

No significant difference in the risk of serious infections between etanercept and infliximab biosimilars and their original brand-name medications was identified.

The Top 5 Biosimilar Articles for the Week of December 30

January 3rd 2025

By Cameron Santoro

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

Senators Introduce Bipartisan Legislation to Protect Skinny Labeling

January 2nd 2025

By Skylar Jeremias

To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

Cetuximab Biosimilar Receives NMPA Approval for RAS/BRAF Wild-Type CRC

January 1st 2025

By Courtney Flaherty

First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.

The Top 5 Most-Read Biosimilar Articles of 2024

December 31st 2024

By Skylar Jeremias

The top 5 biosimilar-related articles of the year highlight a significant shift in the pharmaceutical industry, with projections indicating strong uptake in biosimilars at the expense of the originator products, despite challenges like uptake disparities and safety concerns.

The Top 5 Most-Read Ophthalmology Articles of 2024

December 30th 2024

By Skylar Jeremias

The 2024 surge in FDA approvals for aflibercept biosimilars reflects significant progress in offering cost-effective treatments for retinal conditions like neovascular age-related macular degeneration, although patent disputes pose challenges to their market entry and adoption.

Top 5 Most-Read Rheumatology Articles of 2024

December 30th 2024

By Skylar Jeremias

The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.