Biosimilars Regulatory Roundup: February 2025

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

Regulatory and Business Updates

On February 17, the FDA approved Merilog (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.¹ Two insulin glargine biosimilars, Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr), were previously approved, making Merilog the third overall insulin biosimilar to be greenlit by the FDA.

The FDA and European Medicines Agency (EMA) both approved 2 of Samsung Bioepis' biosimilars (denosumab-dssb; SB16) referencing Prolia/Xgeva (denosumab).² SB16 will be marketed as Ospomyv in the US and Obodence in Europe when indicated for the treatment or prevention of osteoporosis and Xbryk in both regions when used to prevent skeletal fractures in patients with bone metastases. These approvals come nearly a year after the FDA approved the first denosumab biosimilars, and the FDA granted interchangeability for Ospomyv and Xbryk.

Later in the month, the European Commission (EC) granted marketing authorization to Eydenzelt, an aflibercept biosimilar manufactured by Celltrion, as well as to 2 of the company's denosumab biosimilars, Stoboclo and Osenvelt.³ Eydenzelt references Eylea (aflibercept), an anti–vascular endothelial growth factor agent that works by changing how much blood is able to access the retina. Stoboclo references Prolia, which is indicated for osteoporosis; Osenvelt references Xgeva, indicated for the treatment and prevention of bone fractures in patients at an increased risk of fracture due to bone metastases.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for 3 biosimilars, with 1 aflibercept biosimilar from Amgen and 1 pegfilgrastim biosimilar from CuraTeQ Biologics moving on to be reviewed by the European Commission (EC).⁴ The CHMP also recommended new indications for nivolumab (Opdivo) and ipilimumab (Yervoy), both reference products with several biosimilars in development. Should they be approved, the new indication for Opdivo and Yervoy will expand the reach of future biosimilars referencing these agents.

While the FDA and EMA both require high similarity between biosimilars and reference products, differing regulatory requirements for approval pose challenges, according to a recent review.⁵ Novel statistical methods such as simultaneous CIs and multiplicity-adjusted two one-sided tests could help mitigate these challenges, the authors suggested.

Policy Updates

The US Senate made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS in a 52-48 vote.⁶ Although it appeared some Republicans were hesitant, the majority party threw their support behind the longtime vaccine skeptic, critic of processed foods, and initiator of the Make America Healthy Again agenda.

Lastly, in an episode of Not So Different, "Will the FTC Be More PBM-Friendly Under a Second Trump Administration?" Joe Wisniewski from Turquoise Health discussed key issues in the Federal Trade Commission's second interim report on pharmacy benefit managers (PBMs).⁷ These included preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could influence PBM practices.

References

1. Jeremias S. FDA approves first insulin aspart biosimilar. The Center for Biosimilars^®. February 17, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-insulin-aspart-biosimilar

2. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars. January 26, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/fda-ema-approve-second-pair-of-denosumab-biosimilars

3. Jeremias S. EC approves Celltrion denosumab, aflibercept biosimilars. The Center for Biosimilars. January 20, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/ec-approves-celltrion-denosumab-aflibercept-biosimilars

4. Jeremias S. CHMP pushes 3 biosimilars forward, spelling hope for ophthalmology, supportive care markets. The Center for Biosimilars. February 6, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/chmp-pushes-3-biosimilars-forward-spelling-hope-for-ophthalmology-supportive-care-markets

5. Santoro C. Biosimilar approvals streamlined with advanced statistics amidst differing regulatory requirements. The Center for Biosimilars. February 25, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/biosimilar-approvals-streamlined-with-advanced-statistics-amidst-differing-regulatory-requirements

6. Mattina C. Robert F. Kennedy Jr confirmed as HHS secretary, nearly along party lines. The Center for Biosimilars. February 13, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/robert-f-kennedy-jr-confirmed-as-hhs-secretary-nearly-along-party-lines

7. Jeremias S. Will the FTC be more PBM-friendly under a second Trump administration? The Center for Biosimilars. February 23, 2025. Accessed February 28, 2025. https://www.centerforbiosimilars.com/view/will-the-ftc-be-more-pbm-friendly-under-a-second-trump-administration-