A phase 3 clinical trial found that the ustekinumab biosimilar CT-P43 demonstrated equivalent efficacy, safety, and ...

One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable ...

Real-world evidence shows switching between etanercept products and etanercept biosimilars preserves efficacy and safety, ...

Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps ...

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Biologics eat 51% of drug spending despite 5% of prescriptions, but FDA's new draft guidance hopes more competition can close ...

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 ...

A new study confirms KM118, a proposed biosimilar to pertuzumab, shows pharmacokinetic similarity and safety, paving the way for affordable HER2-positive breast cancer treatments. In HER2-positive ...

Denosumab biosimilars enhance treatment access for postmenopausal osteoporosis, demonstrating equivalent efficacy and safety to reference products in recent trials. As biosimilars move into broader ...

Switching from aflibercept to ranibizumab biosimilars maintains stability in nAMD treatment, offering a cost-effective solution for long-term management. A growing share of people receiving long-term ...

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 The FDA has issued draft guidance that ...

CT-P47 emerges as a promising tocilizumab biosimilar, demonstrating comparable efficacy and safety in rheumatoid arthritis treatment, enhancing access and affordability. CT-P47, a biosimilar candidate ...