Biosimilar Updates: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

This article originally appeared on The American Journal of Managed Care^®'s sister site, The Center for Biosimilars^®.

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.

Celltrion Adalimumab Partnership With Costco

Celltrion USA has announced that its FDA-approved biosimilar adalimumab-aaty (Yuflyma), a high-concentration, citrate-free alternative to Humira, is now included in the Costco Member Prescription Program.¹ This biosimilar is approved for conditions including rheumatoid arthritis, juvenile idiopathic arthritis, and Crohn disease.

Since October 1, 2023, adalimumab-aaty has been available through Costco Specialty Pharmacy for self-funded employer plans. The new announcement means that the biosimilar is now accessible to all Costco members. In the news release, Francine Galante, vice president of market access at Celltrion USA, expressed enthusiasm about the partnership with Costco, emphasizing the benefits of increased patient choice and reduced health care costs.

The Costco Member Prescription Program provides eligible members and their dependents with lower prices on adalimumab-aaty and other drugs at participating pharmacies, benefiting uninsured individuals or those denied coverage by their insurers.

"Celltrion is well positioned for continued growth in the U.S. market, which will increase competition and, ultimately, access to high-quality biosimilars and biologic products at a reduced cost," Tom Nusbickel, chief commercial officer at Celltrion USA, said in the release. "To further enhance patient access, we are increasing our manufacturing capacity and strengthening our supply chain resilience to ensure delivery of patient treatment."

Amgen Sues Samsung Bioepis Over Denosumab Candidate

Amgen has filed a lawsuit against Samsung Bioepis in a New Jersey federal court, challenging the proposed denosumab biosimilars of its popular bone drugs, Prolia and Xgeva (reference denosumab), according to a report from Reuters.² The lawsuit claims that Samsung's biosimilars infringe on 34 of Amgen's patents related to these drugs. Amgen is seeking a court order to prevent Samsung from manufacturing and selling these biosimilars, along with unspecified monetary damages.

Samsung Bioepis has applied to the FDA for approval to market biosimilars of Prolia, which treats osteoporosis, and Xgeva, which prevents fractures in bone-cancer patients. Amgen reported substantial sales of Prolia and Xgeva in the US, totaling over $4.2 billion last year.

The FDA has already approved Sandoz's biosimilars for Prolia and Xgeva (Jubbonti and Wyost respectively; denosumab-bddz), which are set to enter the US market by May 2025 following a separate patent settlement.³ Amgen's lawsuit alleges that Samsung's biosimilars infringe on patents covering the active ingredient denosumab and related technologies. The case is filed under Amgen Inc v Samsung Bioepis Co in the US District Court for the District of New Jersey.

Phase 1 Denosumab Biosimilar Results

GlycoNex, a biotechnology firm specializing in glycan-directed cancer therapies, has successfully completed a phase 1 clinical trial for its denosumab biosimilar, SPD8, developed in partnership with Mitsubishi Gas Chemical Company.⁴ The trial, involving healthy postmenopausal women, demonstrated that SPD8 met the primary endpoint of clinical pharmacokinetic equivalence, showing comparable safety, pharmacokinetics, and pharmacodynamics to the reference drug.

With these encouraging results, GlycoNex is preparing to initiate phase 3 clinical trials for SPD8, scheduled to begin in the fourth quarter of 2024. This next phase will evaluate the biosimilar’s efficacy, safety, and immunogenicity in a larger group of patients with osteoporosis. The company is collaborating with regulatory authorities to ensure the trial's design meets all necessary standards.

GlycoNex said it’s aiming to offer a cost-effective alternative to denosumab. The company is also pursuing global development opportunities to enhance treatment options for osteoporosis.

References

1. Celltrion USA announces incorporation of adalimumab-aaty, a Humira biosimilar, to the Costco Member Prescription Program. Press release. Cellrion USA; August 12, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/celltrion-usa-announces-incorporation-of-adalimumab-aaty-a-humira-biosimilar-to-the-costco-member-prescription-program-302220446.html

2. Brittain B. Amgen sues Samsung biotech unit over bone drug copies. Reuters. August 13, 2024. Accessed August 20, 2024. https://www.reuters.com/legal/litigation/amgen-sues-samsung-biotech-unit-over-bone-drug-copies-2024-08-13/

3. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimlars®. March 5, 2024. Accessed August 20, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

4. GlycoNex successfully completes phase 1 study of denosumab biosimilar, SPD8. Press release. GlycoNex; August 19, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/glyconex-successfully-completes-phase-1-study-of-denosumab-biosimilar-spd8-302224433.html