Teva Agrees to Strategic Partnerships with Formycon AG, Klinge Biopharma, & Samsung Bioepis

Image Credit: Adobe Stock Images/Katerina

Teva Pharmaceuticals announced two strategic collaborations to expand its biosimilar portfolio and enhance access to high-cost biologics across key markets.

The first deal, which is with Formycon AG and Klinge Biopharma, aims to commercialize FYB203, a biosimilar to Eylea (aflibercept), in most European countries and Israel. According to Teva, the collaboration will combine its commercial expertise in the biosimilar space with Formycon’s experience in developing these medications in highly regulated countries. Currently, Klinge maintains exclusive global commercialization rights to FYB203. Pending regulatory approval, Teva will market the product under the name Ahzantive for severe retinal diseases.¹

"We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio/Ongavia) in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve,” said Richard Daniell, EVP, European commercial, Teva, in a press release.

Under terms of the deal, Teva will spearhead commercialization efforts in the specified region, with Klinge receiving milestone payments as well as a percentage of the treatment’s revenue.

FYB203 was first approved by the FDA in June 2024. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation for the marketing authorization of FYB203 in November 2024. A final European Commission decision is expected by the end of the month.¹

“With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio/Ongavia) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product,” said Nicola Mikulcik, chief business officer, Formycon, in the press release.

Teva also recently announced a collaboration with Samsung Bioepis for the commercialization of Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab) for the treatment of rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, and generalized myasthenia gravis (gMG). Epysqli was first approved by the FDA last July in patients with PNH. In November 2024, it was granted approval to treat gMG in adults who are anti-acetylcholine receptor antibody positive. The treatment is also currently approved in Europe and South Korea.²

“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 PNH, aHUS and gMG, pose many but unique challenges to patients and their families, and we are dedicated to enhancing the lives of patients including those with rare diseases,” said Kyung-Ah Kim, president, CEO, Samsung Bioepis, in a press release. “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.”

Under terms of the deal, Samsung Bioepis will lead development regulatory registration, manufacture, and supply, while Teva will work on commercialization efforts in the United States. Financial terms are currently being kept confidential.²

“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,” said Chris Fox, EVP, US commercial, Teva, in the press release.

References

1. Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel. Teva. January 13, 2025. Accessed January 14, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-collaboration-to-commercialize-formycons-biosimilar-candidate-to-eylea-aflibercept-in-/

2. Teva and Samsung Bioepis Enter into a Strategic Partnership for Commercialization of EPYSQLI® (eculizumab-aagh) in the United States. Teva. January 10, 2025. Accessed January 14, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-and-samsung-bioepis-enter-into-a-strategic-partnership-for-commercialization-of-epysqli-eculizumab/