Robert Cook, PhD, of Teva explains how analytical characterization and PK data will shape its next biosimilar program.

Teva's Robert Cook, PhD, explains the clinical data, interchangeability, and supply strategy behind its Degevma and Ponlimsi ...

Bipartisan bills would automatically delay Medicare price talks for biologics facing biosimilars as California expands ...

The FDA approved Teva's Degevma, a denosumab biosimilar to Xgeva for cancer-related bone disease, rounding out its Xgeva/Prolia portfolio.

After much anticipation, the FDA approves the first interchangeable biosimilar, which is hoped to bring down the high cost of insulin. The FDA has approved Biocon Biologic's Semglee insulin glargine ...

FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech’s Entyvio rival enters FDA review—boosting access. Biosimilar developers across the globe advanced their pipelines ...

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 The FDA has issued draft guidance that ...

Bevacizumab-bvzr…pegfilgrastim-bmez…infliximab-axxq…. Have you ever wondered what is behind the seemingly random letter strings attached to the nonproprietary names (also known as “proper names”) of ...

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

The Center for Biosimilars® looks back at the first year of adalimumab biosimilars on the US market, including every product launch and approval as well as market trends and pricing strategies. Since ...

The FDA approved Avtozma, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be ...

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 ...