On January 10, Samsung Bioepis announced a new arrangement with Teva to commercialize the former’s eculizumab biosimilar Epysqli (reference product, Soliris) in the US.
In a press release, Kyung-Ah Kim, the recently promoted President and CEO of Samsung Bioepis, stated “We are excited to announce this new strategic partnership for a biosimilar which has a significant potential to increase access for rare disease patients, who are suffering from the high-cost and the limited availability of the treatment. Rare diseases such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis, pose many unique challenges to patients and their families, and we are dedicated to enhancing the lives of patients including those with rare diseases. This collaboration is a testament of our long-term commitment in the biosimilars business, as a leading biopharmaceutical company with a mission to innovate access to treatments for healthcare systems, payers, providers, and patients. We will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the US.”
Chris Fox, Executive Vice President, US Commercial at Teva, said “We are excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients. The collaboration enables us to leverage our extensive commercial capabilities and is aligned with our Pivot to Growth strategy, introducing a new biosimilar to our broad biosimilar portfolio, accelerating access to affordable treatment options.”
Epysqli is awaiting launch, after its July 2024 approval in the US. This is the first strategic agreement between these two important biosimilar players. Teva has three biosimilars on the market today, and a broad biosimilar pipeline. Samsung Bioepis has seven FDA-approved biosimilars and at least two others in the pipeline.
In Other Biosimilar News
Tanvex Biopharma USA, the US subsidiary of Taiwan-based Tanvex Biopharma, received its second complete response letter from the FDA regarding the trastuzumab biosimilar TX-05. The original 351(k) application was filed in October 2021, and the FDA rejection came in July 2022. The latest biologic license application was submitted in July 2024. The most recent complete response letter cited problems involving a third-party subcontractor for Tanvex.
The reference drug is Herceptin, and Tanvex would face heavy competition in this market, with six approved biosimilar products and five already on the market. Several were launched more than 5 years ago.
