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 ...

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

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

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 The FDA has issued draft guidance that ...

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 ...

Eli Lilly and Company has launched its insulin glargine biosimilar, Rezvoglar (insulin glargine-aglr), on the US market, making it the second interchangeable insulin biosimilar to become commercially ...

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more ...

FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings. The US biosimilar market officially capped off a ...

The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on ...

After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th ...