Biosimilars News Roundup: August 2025

Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals

January 11th 2025

By Skylar Jeremias

Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

The Top 5 Biosimilar Articles for the Week of January 6

January 10th 2025

By Cameron Santoro

Here are the top 5 biosimilar articles for the week of January 6, 2025.

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

January 9th 2025

By Cameron Santoro

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

Equivalence Confirmed: CT-P41 Paves the Way for Affordable Osteoporosis Care

January 8th 2025

By Skylar Jeremias

Celltrion’s denosumab biosimilar demonstrated equivalent efficacy, safety, and immunogenicity compared with the originator in a phase 3 trial involving postmenopausal women with osteoporosis, paving the way for improved accessibility and cost savings in osteoporosis treatment.

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.