Samsung Bioepis Set to Launch Stelara Biosimilar in 2025 Amid Challenges for Medicare Price Negotiation Exemption

December 1, 2023

Samsung Bioepis recently finalized an agreement allowing its Stelara biosimilar, SB17, to launch in February 2025. This move introduces competition against Johnson & Johnson’s (J&J) successful anti-inflammatory drug, Stelara. However, this competition is not expected to be substantial enough to exclude Stelara from Medicare price negotiations under the Inflation Reduction Act. According to the Act, drugs without generic or biosimilar competition by 2026 will be subject to government price negotiation. To be considered as “bona fide competition” and thus exempt from these negotiations, substantial market impact must be evident by August 1, 2024.

J&J expects another biosimilar competitor, Amgen’s Wezlana, to launch on January 1, 2025. However, this timeline surpasses the deadline to influence the Medicare negotiation decision. Anna Kaltenboeck, a specialist in drug reimbursement, emphasizes that more than mere market presence of a biosimilar is required. The Centers for Medicare & Medicaid Services (CMS) requires clear evidence of significant market uptake, a challenging goal for a new biosimilar.

SB17, under review by the FDA and set to be marketed by Sandoz upon approval, arises from a patent litigation settlement with J&J, though the exact terms are undisclosed. If approved, it will launch on February 22, 2025. Stelara’s significant revenue impact is evident, 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.

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

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[Source: Endpoints, December 1st, 2023]

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