Ustekinumab-Aauz

TEL AVIV, Israel I January 13, 2025 I Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) today announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH (Klinge) and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon’s biosimilar candidate to Eylea ® (aflibercept) in Europe, excluding Italy, and in Israel. This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries. Klinge has in-licensed the exclusive global commercialization rights to FYB203 from Formycon. Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE ®3 , subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product’s revenue. Formycon is a leading, independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. Richard Daniell, Executive Vice President, European Commercial at Teva said: “We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio ®4 /Ongavia ®5 ) 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.” Commenting on the agreement, Nicola Mikulcik, CBO of Formycon, says, “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.” In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the marketing authorization of FYB203 under the brand names AHZANTIVE ® / Baiama ®6 . The European Commission’s decision on approval is expected in the second half of January 2025. Eylea ® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea ® achieved global sales of approximately USD 9 billion, including USD 2.9 billion in the European market, further underscoring its status as the highest-revenue drug in the anti-VEGF therapy sector. About Teva: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon shares are listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and are part of the selection index SDAX and TecDAX. Further information can be found at: https://www.formycon.com/ 1) Eylea ® is a registered trademark of Regeneron Pharmaceuticals Inc. 2) Lucentis ® is a registered trademark of Genentech Inc. 3) AHZANTIVE ® is a registered trademark of Klinge Biopharma GmbH 4) Ranivisio ® is a registered trademark of Bioeq AG 5) Ongavia ® is a registered trademark of Teva Pharmaceutical Industries Ltd. 6) Baiama ® is a registered trademark of Klinge Biopharma GmbH SOURCE: Teva Pharmaceutical Co

The development agreement will see Fresenius Kabi’s cell therapy processing technologies integrated into Cellular Origins’ robotic platform. Credit: Kotin/Shutterstock. Fresenius Kabi and Cellular Origins have announced a partnership to advance the field of cell and gene therapy (CGT) by automating the manufacturing process. Fresenius Kabi’s cell therapy processing technologies will be integrated into Cellular Origins’ Constellation robotic platform. The partnership’s primary objective is to streamline the production of cell therapies at scale, maintaining the use of developers’ preferred tools for processing. This initiative automates the production of advanced therapies, aiming to enhance production efficiency and reduce the risk of human error-induced inconsistencies. The integration process will initially concentrate on Fresenius Kabi’s Cue cell processing system. This system is expected to be fully automated within Constellation, covering aspects from consumable transport to full process operation and data management. See Also: mRNA Covid-19 vaccines may boost cancer immunotherapy effectiveness UNICEF secures one million mpox vaccines for Africa Cellular Origins CEO Dr Edwin Stone stated: “Cellular Origins has developed Constellation to enable fully industrialised manufacture of cell and gene therapies. “Forming strong collaborations is essential to ensuring the industry can implement the transformative power of automation whilst using the tools that are best for the biology and, therefore, for patients. Fresenius Kabi is an industry-leading developer of automated technologies to support the production of cell therapies. “This is why we are excited to be working closely with their team to unlock the power of automation throughout the entire manufacturing process, with the goal of bringing life-saving therapies to patients, faster and more affordably.” The companies will begin their integration efforts with the Cue cell processing system, which is tailored for automated and precise small-volume cell processing. Following success with Cue, the partnership then plans to extend its focus to include Fresenius Kabi’s broader cell therapy technology portfolio, such as the Lovo cell processing system and other products currently under development. In October 2024, Fresenius Kabi won US Food and Drug Administration approval for Otulfi (ustekinumab-aauz), a Stelara biosimilar. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy