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Top 5 Most-Read Regulatory Articles of 2025
Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and competition in health care.
In 2025, the FDA continued to rapidly expand access to biosimilars, particularly in complex therapeutic areas like bone health, immunology, and diabetes. Key regulatory milestones included the approval of multiple pairs of denosumab biosimilars and the designation of interchangeability for new biosimilars referencing insulin aspart and omalizumab, enhancing competition and potentially lowering treatment costs.
Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and competition in healthcare.
Here are the top 5 biosimilar regulatory news items:
5. FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
The FDA approved Fresenius Kabi Biopharma's denosumab biosimilars, Conexxence and Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions. Conexxence and Bomyntra reference Prolia and Xgeva, respectively, and were approved for all indications of their reference products. Conexxence (60 mg/mL) is approved for use in various adult patient populations at high risk for fractures, including osteoporosis, and individuals receiving long-term glucocorticoid therapy. Bomyntra (120 mg/1.7 mL) is approved to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors, among other indications. Fresenius Kabi Biopharma plans to launch these biosimilars in the US market in mid-2025.
4. FDA Approves Starjemza as New Stelara Biosimilar
The FDA approved Starjemza (ustekinumab-hmny) as a biosimilar to Stelara (ustekinumab) for the treatment of several rheumatic and gastrointestinal conditions. Starjemza, developed through a partnership between Hikma Pharmaceuticals and Bio-Thera Solutions, is the eighth ustekinumab biosimilar to receive FDA approval. The approval was based on data from phase 1 and phase 3 clinical studies, including a trial in patients with moderate-to-severe plaque psoriasis, which confirmed Starjemza's comparable efficacy, safety, and immunogenicity relative to the reference product. Hikma aims to utilize its commercial capabilities to launch this product to benefit patients.
3. FDA Approves Third Pair of Denosumab Biosimilars
The FDA approved Celltrion's denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo), for all indications of the reference products Prolia and Xgeva, respectively. This approval marks the third FDA green light for a denosumab biosimilar product pair. Stoboclo is indicated for osteoporosis (referencing Prolia), while Osenvelt references Xgeva, used for treating and preventing bone fractures in high-risk patients due to bone metastases. The approval was based on a phase 3 trial in postmenopausal women with osteoporosis that showed comparable efficacy in improving lumbar spine bone mineral density, as well as comparable safety profiles. The products are anticipated to launch in the US in June 2025 as part of a settlement agreement with the reference product manufacturer, Amgen.
2. FDA Approves Kirsty as First Interchangeable Insulin Aspart Biosimilar
The FDA approved Kirsty (insulin aspart-xjhz), establishing it as the first rapid-acting interchangeable biosimilar product to reference Novolog (insulin aspart). Kirsty is indicated to improve glycemic control in both adult and pediatric patients with diabetes. The interchangeable status is highly significant because it allows the biosimilar to be substituted for the reference product at the pharmacy level without a new prescription, depending on state laws, which is expected to streamline patient access and further drive competition. This approval is critical for enhancing access to more affordable insulin options for the over 8.4 million Americans who depend on insulin therapy.
1. FDA Approves First Omalizumab Biosimilar
Celltrion USA’s Omlyclo (omalizumab-igec) gained FDA approval as the first biosimilar to reference Xolair (omalizumab), and it was also approved with interchangeability status. Omlyclo is the first respiratory biosimilar approved in the US. The biosimilar is approved for a range of allergic and inflammatory conditions, including moderate-to-severe asthma in adults and children aged 6 and older, chronic spontaneous urticaria, chronic sinus inflammation/nasal polyps, and reducing allergic reactions in patients 12 months and older with serious food allergies (in conjunction with strict food avoidance). The approval also included labeling for an unbranded biological version, which aligns with dual-pricing strategies used in other chronic disease markets, such as insulin glargine and adalimumab.
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