Bone Health

Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US market entry delays.

Biosimilar denosumab offers significant cost savings and improved access to treatment, alleviating financial burdens in oncology care while enhancing patient outcomes.

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

The European Commission (EC) approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

New denosumab biosimilars, Bildyos and Bilprevda, enhance access to affordable osteoporosis and bone disease treatments, promising significant patient benefits.

Biosimilar LY01011 is equivalent to the reference product denosumab for treating bone metastases in solid tumors, demonstrating similar efficacy in reducing bone metabolism biomarkers, comparable safety profiles, and a lack of unexpected adverse reactions.

The US biosimilar market expands with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.

Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis report impressive Q1 2025 growth, driven by strong denosumab biosimilars and expanding portfolios.

The biosimilar industry faces awareness challenges among health care professionals (HCPs), which must be addressed to increase cost savings and patient access to treatments.

New research confirms denosumab biosimilar SB16 matches Prolia in efficacy, offering a cost-effective treatment option for postmenopausal osteoporosis.

Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.

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.

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.

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.

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).

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.