Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.

Biologics eat 51% of drug spending despite 5% of prescriptions, but FDA's new draft guidance hopes more competition can close that gap.

A new analysis dives into why Europe’s eye clinics lag on biosimilars and how education, guidance, and smarter tenders could unlock €747 million in savings.

CHMP backs a fifth teriparatide biosimilar as biosimilars in Europe grow, while US patent fights threaten new biologic competition.

A phase 2 trial showed that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar can elicit responses in advanced liver cancer.

Budget impact analysis finds omalizumab biosimilars in Europe could cut payer costs by €641M in 5 years, expanding access and ...

Biosimilars save billions, but FDA’s new guidance, physician concerns, and Humira switchbacks reveal hurdles to a sustainable US market. Since the first launch in 2015, biosimilars have fundamentally ...

Real-world India data show trastuzumab emtansine biosimilars deliver meaningful PFS and manageable safety in heavily pretreated HER2+ metastatic breast cancer.

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability. The FDA has issued draft guidance that ...

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market. The economic impact of biosimilars on the ...

CT-P6 demonstrates strong efficacy and safety in HER2-positive advanced gastric cancer, achieving an 82% disease control rate in real-world settings. Data from a post-marketing surveillance study of ...

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions. The FDA has announced a significant advancement in diabetes ...