Sunday, February 9, 2025

Samsung Bioepis’ Stelara Biosimilar Faces Challenges for Medicare Price Negotiation Exemption

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Samsung Bioepis has sealed a deal permitting its Stelara biosimilar, SB17, to be launched in February 2025, potentially creating competition for Johnson & Johnson’s (J&J) successful anti-inflammatory medication, Stelara. Despite the potential competition, it is not anticipated to be substantial enough to exclude Stelara from Medicare price negotiations under the Inflation Reduction Act. The Act mandates that drugs without generic or biosimilar competition by 2026 will be subject to government price negotiation. To be exempted from these negotiations, a significant market impact must be evident by August 1, 2024.

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Upcoming Biosimilar Launches Face Hurdles in Influencing Medicare Negotiations

Another competitor, Wezlana by Amgen, is expected to be launched on January 1, 2025. However, this timeline surpasses the deadline to influence the Medicare negotiation decision. Drug reimbursement expert, Anna Kaltenboeck, highlights that more than just the market presence of a biosimilar is necessary. The Centers for Medicare & Medicaid Services (CMS) necessitates clear evidence of significant market uptake, a challenging goal for a new product.

SB17, currently under FDA review and expected to be marketed by Sandoz upon approval, results from a patent litigation settlement with J&J, although the exact terms are not disclosed. If approved, it will be launched on February 22, 2025. Stelara’s significant revenue impact is clear, with $6.4 billion in U.S. sales in 2022 and $2.6 billion in costs to Medicare Part D from June 2022 to May 2023.

Biosimilar

Challenges Await Biosimilar Launches for Stelara in 2025

Other biosimilar candidates include Fresenius Kabi and Formycon’s version, intended to be launched by April 15, 2025, under an arrangement with J&J. Teva and Alvotech also had a deal with J&J for a February 2025 launch. However, their candidate encountered FDA rejection due to deficiencies at its production site.

Hence, while Samsung Bioepis’ Stelara biosimilar is set to be launched in 2025, it faces hurdles in achieving a Medicare price negotiation exemption. The introduction of biosimilar products does not guarantee significant market impact, and the product must show evidence of considerable market uptake to influence Medicare negotiation decisions.


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