Bone Health

FDA, EMA Approve Second Pair of Denosumab Biosimilars

February 17th 2025

By Skylar Jeremias

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

Teriparatide Biosimilar Shows Comparable Efficacy to Reference Drug in Postmenopausal Osteoporosis

February 17th 2025

By Cameron Santoro

Article

Researchers treated postmenopausal women with osteoporosis with teriparatide biosimilar RGB-10, which improved their bone health measures and reduced fracture risk comparably to reference teriparatide.

Biosimilar Teriparatide Matches Forteo in Safety and Fracture Risk

January 23rd 2025

By Skylar Jeremias

Article

Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.

A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

January 21st 2025

By Skylar Jeremias

Article

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

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

January 11th 2025

By Skylar Jeremias

Article

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.

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

January 8th 2025

By Skylar Jeremias

Article

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.

Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator

December 11th 2024

By Skylar Jeremias

Article

Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.

Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration

December 10th 2024

By Skylar Jeremias

Article

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone

November 26th 2024

By Ashling Wahner

Article

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data

November 19th 2024

By Skylar Jeremias

Article

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.