Bone Health

Biosimilar Natalizumab-sztn Shows Comparable Efficacy and Safety to Tysabri in RRMS

March 25th 2025

By Cameron Santoro

Article

Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option.

Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors

March 11th 2025

By Ha Kung Wong, JD

Article

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

FDA Approves Third Pair of Denosumab Biosimilars

March 4th 2025

By Skylar Jeremias

Article

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

EC Approves Celltrion Denosumab, Aflibercept Biosimilars

February 20th 2025

By Skylar Jeremias

Article

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

FDA, EMA Approve Second Pair of Denosumab Biosimilars

February 17th 2025

By Skylar Jeremias

Article

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.