Samsung Bioepis and Teva Expand Global Biosimilar Partnership to Advance Up to Six Candidates
Samsung Bioepis Co., Ltd. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) have announced an expanded strategic collaboration to develop and commercialize up to six potential biosimilar candidates, strengthening their efforts to broaden access to biologic medicines across international markets. The agreement includes two confirmed investigational biosimilar candidates: SB41, which references Fasenra® (benralizumab), and SB44, which references Ilaris® (canakinumab).
Under the terms of the global license, development, and commercialization agreement, Samsung Bioepis will oversee the development, regulatory registration, and manufacturing of the biosimilar candidates. Teva will lead commercialization across global markets, including the United States, Europe, and Canada. The agreement also includes an option to extend the collaboration into additional territories, providing the companies with flexibility to expand their commercial reach as the programs progress.
The partnership builds on an established relationship between the two companies and reflects their shared interest in strengthening their positions in the global biosimilars market. By combining Samsung Bioepis’ development and manufacturing capabilities with Teva’s international commercial infrastructure, the companies aim to advance additional treatment options for patients and healthcare systems.
The collaboration also builds on previous commercial achievements, including the successful commercialization of EPYSQLI® (eculizumab-aagh) in the United States. The companies have subsequently expanded their partnership to include OPUVIZ® (aflibercept) in Canada. The new agreement extends this relationship to additional potential biosimilar products and reinforces their commitment to developing a broader portfolio.
Advancing Two Investigational Biosimilar Candidates
The agreement identifies SB41 and SB44 as two confirmed candidates within a potential portfolio of up to six biosimilars. Both programs reference established biologic medicines, creating opportunities for the companies to pursue additional treatment options through biosimilar development.
SB41 is a proposed biosimilar referencing Fasenra® (benralizumab), a biologic medicine used in the treatment of certain patients with severe eosinophilic asthma. The reference product targets the interleukin-5 receptor alpha, or IL-5Rα, expressed on eosinophils and basophils. These immune cells are involved in inflammatory processes associated with several conditions, including eosinophilic asthma.
Eosinophils are a type of white blood cell that can contribute to airway inflammation in certain forms of asthma. Biologic treatments targeting pathways involved in eosinophil activity have become an important option for eligible patients whose disease remains inadequately controlled with other therapies. The development of a biosimilar referencing benralizumab would add another potential product to the companies’ development pipeline in this treatment area, subject to the necessary clinical, regulatory, and commercial milestones.
SB44 is an investigational biosimilar candidate referencing Ilaris® (canakinumab), a monoclonal antibody that targets interleukin-1 beta, or IL-1β. This inflammatory signaling protein plays a role in several autoinflammatory conditions. Canakinumab is used for certain approved indications involving inflammatory and autoinflammatory diseases.
The development of a biosimilar referencing canakinumab would extend the collaboration into another biologic treatment category. It also reflects the companies’ intention to develop a portfolio spanning multiple reference products rather than concentrating exclusively on one medicine or therapeutic area.
Both SB41 and SB44 remain investigational biosimilar candidates under the announced agreement. The companies have not specified development timelines, anticipated regulatory submission dates, launch schedules, or the identities of the other potential candidates covered by the broader arrangement.
The agreement encompasses up to six potential biosimilar candidates, indicating that the collaboration could extend beyond the two programs identified at the time of the announcement. Any additional candidates would be subject to the applicable terms of the partnership and subsequent development decisions.
Samsung Bioepis to Lead Development and Manufacturing
Samsung Bioepis will be responsible for the development, regulatory registration, and manufacturing of the biosimilar candidates included in the agreement. These responsibilities place the company at the center of the product development process, from advancing the investigational programs through the regulatory requirements necessary for potential market entry.
Biosimilar development involves demonstrating that a proposed product is highly similar to an approved reference biologic and that there are no clinically meaningful differences in safety, purity, and potency. Because biologic medicines are produced using living systems and can have complex molecular structures, the development process requires extensive analytical characterization and an appropriate body of supporting evidence.
Regulatory requirements vary by jurisdiction and product. Depending on the relevant regulatory framework and the characteristics of a candidate, developers may need to provide analytical, functional, pharmacokinetic, clinical, manufacturing, and other data to support a biosimilar application.
Samsung Bioepis’ responsibilities under the agreement include managing the development programs and manufacturing activities, as well as pursuing regulatory registration in the markets covered by the collaboration. The company will therefore be responsible for preparing the products for potential commercialization, subject to successful development and the relevant regulatory decisions.
Manufacturing is another important element of biosimilar development. Consistent production processes, quality controls, and reliable supply are necessary to support regulatory compliance and commercial availability. By assigning manufacturing responsibilities to Samsung Bioepis, the agreement establishes a defined division of work between the two partners.
The arrangement also allows the companies to concentrate on complementary areas of expertise. Samsung Bioepis will focus on product development and supply, while Teva will use its commercial capabilities to support the potential introduction of the products into international markets.
Teva to Lead Global Commercialization
Teva will be responsible for commercializing the biosimilar candidates across global markets, including the United States, Europe, and Canada. The agreement also provides an option to expand the partnership into other territories, potentially broadening the geographic scope of the collaboration.
For Teva, the agreement represents an expansion of its biosimilars portfolio and a continuation of its strategy to strengthen its position in biopharmaceuticals. Commercializing biosimilars requires more than securing regulatory approval. Companies must also establish market access, engage with healthcare professionals and other stakeholders, navigate reimbursement systems, and develop reliable distribution channels.
Teva’s global commercial infrastructure is expected to play a central role in the partnership. Its responsibilities will include bringing the products to market following the completion of the relevant development and regulatory processes.
The United States, Europe, and Canada represent significant markets for biologic medicines, although market access conditions, pricing arrangements, reimbursement policies, and regulatory requirements differ across jurisdictions. A coordinated international commercialization strategy can help companies address these differences while building a broader presence for their products.
The option to expand into additional territories provides further flexibility. As the development programs advance, the companies may have the opportunity to assess additional markets and determine whether extending the partnership would support their commercial objectives.
However, the announcement does not specify the commercial terms of the agreement, including upfront payments, milestone payments, royalties, development costs, or anticipated revenue contributions. It also does not establish a timeline for potential product launches.
Building on an Established Collaboration
The expanded agreement follows earlier collaboration between Samsung Bioepis and Teva, which has already resulted in commercial progress in the biosimilars sector.
One of the products associated with their existing partnership is EPYSQLI® (eculizumab-aagh), which has been successfully commercialized in the United States. Eculizumab is a monoclonal antibody that inhibits the complement protein C5, a component of the complement system involved in immune defense and certain disease processes.
The companies have also expanded their agreement to include OPUVIZ® (aflibercept) in Canada. Aflibercept is a biologic medicine that inhibits vascular endothelial growth factor, or VEGF, signaling and is used in approved ophthalmic indications.
These products illustrate the breadth of the companies’ previous collaboration across different biologic medicines and therapeutic areas. The new agreement builds on that foundation by introducing additional investigational candidates and establishing the potential for a larger multi-product portfolio.
For both companies, expanding an established relationship may provide operational advantages by building on existing working arrangements and complementary capabilities. The agreement also creates a framework for continued cooperation across development, manufacturing, regulatory activities, and commercialization.
The broader collaboration reflects an approach in which one partner manages the technical and manufacturing aspects of biosimilar development while the other leads market introduction. Such arrangements can enable companies to combine specialized expertise and pursue multiple products under a common strategic framework.
Leadership Perspectives on the Expanded Agreement
Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis, highlighted the importance of expanding the company’s relationship with Teva and advancing additional biosimilar candidates.
“We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines,” Kim said.
She added that Samsung Bioepis would continue to strengthen its biosimilar pipeline and work toward wider availability of these medicines for patients and healthcare systems around the world.
Kim’s comments emphasize the company’s continued focus on biosimilar development and portfolio expansion. The agreement provides another opportunity for Samsung Bioepis to apply its development and manufacturing capabilities to additional reference biologics while working with a partner responsible for commercialization.
Richard Francis, President and Chief Executive Officer of Teva, described biosimilars as an increasingly important component of the company’s broader business strategy.
“Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company,” Francis said.
He characterized the global multi-product agreement as a significant step toward expanding Teva’s biosimilars business, increasing the breadth of its pipeline, and building on the companies’ existing collaboration in the United States.
Francis also highlighted the combination of a growing product portfolio and Teva’s global commercial capabilities as central elements of the partnership. According to the CEO, the expanded collaboration is intended to strengthen the company’s position in biosimilars and its ability to provide additional treatment options to patients worldwide.
Implications for the Biosimilars Market
Biosimilars have become an increasingly important part of the biopharmaceutical industry as healthcare systems look for ways to expand treatment options and manage the costs associated with biologic medicines. These products are developed to be highly similar to already approved biologics, with the potential to introduce additional competition after meeting applicable regulatory requirements.
However, the extent to which biosimilars improve access depends on several factors, including regulatory approval, pricing, reimbursement policies, physician and patient acceptance, supply reliability, and competition within individual therapeutic markets.
The Samsung Bioepis–Teva agreement brings together two companies with defined responsibilities across the biosimilar value chain. Samsung Bioepis will lead development and manufacturing, while Teva will manage commercialization across key international markets. This division of responsibilities provides a structure for advancing multiple candidates and preparing them for potential market entry.
The inclusion of candidates referencing benralizumab and canakinumab also broadens the scope of the collaboration across distinct biologic treatment areas. If development and regulatory requirements are successfully completed, these programs could add further options to the respective markets.
Nevertheless, the announcement represents a development and commercialization agreement rather than confirmation that either candidate has received regulatory approval or is available to patients. The progress of each program will depend on the completion of the required development activities and regulatory review.
Next Steps for the Partnership
The companies’ immediate framework centers on advancing the confirmed SB41 and SB44 programs while retaining the possibility of expanding the collaboration to as many as six potential biosimilar candidates. Samsung Bioepis will manage development, regulatory registration, and manufacturing, and Teva will oversee commercialization in the United States, Europe, Canada, and potentially additional territories under the expansion option.
Further information about development milestones, regulatory submissions, additional candidates, and anticipated launch timelines has not been disclosed in the announcement.
The expanded partnership underscores the companies’ shared focus on biosimilars as part of their longer-term business strategies. By building on their existing commercial relationship and combining development, manufacturing, and global market capabilities, Samsung Bioepis and Teva are establishing a broader framework for advancing potential biosimilar medicines.
The collaboration’s eventual contribution to patient access will depend on the progress of the investigational candidates, regulatory outcomes, manufacturing readiness, and commercial execution. For now, the agreement marks a new phase in the companies’ relationship and creates a pathway for pursuing additional biosimilar opportunities across international markets.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health.