Home » 2026 Global Biosimilars Market Midyear Review » Biosimilar Deals: M&A and Licensing in H1 2026
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The defining feature of H1 2026 dealmaking was the internalization of capability, though not in the same way for every transaction. This chapter of Alira Health’s 2026 Global Biosimilars Market Midyear Review details the three major M&A deals in the time period as well as licensing agreements that made up the majority of transactions between July 2025 through June 2026. In this period, generics companies bought, or agreed to buy, development and manufacturing capability rather than continuing to license assets and/or use contract development and manufacturing organizations. One exception was Sun Pharmaceutical Industries’ acquisition of Organon as an established commercial position rather than capability, since the Organon biosimilars business itself remains a license from Samsung Bioepis. Of the three transactions mentioned below, only the Sandoz purchase of Just-Evotec Biologics has officially closed by the time of the publication of this report (September 2026). The Amneal Pharmaceuticals acquisition of Kashiv BioSciences and the Sun Pharmaceutical Industries acquisition of Organon were signed and announced during H1 2026 and both remained subject to shareholder and regulatory approval as of June 30, 2026.
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Three major biosimilar platform deals, Q4 2025 to H1 2026, by disclosed transaction value. This deal (Sandoz/Just-Evotec Biologics) is major in the space, closed in December 2025, meaning it was not covered by our previous report but in line with the overall dynamics in play for H1 2026.
Source: company disclosures; SEC filing; Alira Health analysis. All three deals are announced/signed; none as closed as of 30 June 2026 except Sandoz/Just-Evotect (completed 5 Dec 2025).
Sandoz/Just-Evotec Biologics EU SAS: Announced November 4, 2025, closed December 5, 2025. Sandoz acquired 100% of Just-Evotec Biologics EU SAS from Evotec SE, including the Toulouse, France, continuous-manufacturing site, together with an indefinite license to the Just-Evotec continuous-manufacturing platform. Sandoz paid approximately $350 million in upfront cash, and Evotec is eligible for license fees, development revenues, and success-based milestones that the parties stated could exceed $300 million over time, together with royalties on a portfolio of up to ten biosimilars in early development. Sandoz and Evotec had partnered since May 2023, and Sandoz secured long-term supply from Toulouse in July 2024, so the transaction removed a contract-manufacturing dependency that Sandoz had already built its supply plan around. The transaction is the only one of the three to have closed by September 2026, and it set the pattern that the two larger H1 2026 transactions followed.
Amneal Pharmaceuticals/Kashiv BioSciences: Announced April 21 to 22, 2026, not yet closed (as per September 2026). Amneal Pharmaceuticals (Nasdaq: AMRX) agreed to acquire 100% of Kashiv BioSciences for $375 million in cash and $375 million in Class A stock at closing, plus contingent payments of up to $350 million tied to United States (US) regulatory milestones and royalties of 25% of gross profit above defined hurdles on certain products for 12 years after closing, giving total potential consideration of approximately $1.1 billion. The structure places approximately 32% of the maximum consideration behind US regulatory and commercial performance, and the equal split between cash and stock limits the cash outlay at closing to $375 million. The transaction illustrates this shift directly, because Amneal Pharmaceuticals acquired the developer it had been licensing from, having taken FYLNETRA® pegfilgrastim from Kashiv BioSciences in 2022 and the omalizumab candidate ADL018 in 2024. Amneal Pharmaceuticals is targeting more than 12 commercial biosimilars by 2030 and expects the transaction to close in H2 2026, subject to shareholder and regulatory approval.
Sun Pharmaceutical Industries/Organon: Announced April 26, 2026, not yet closed (as per September 2026). Sun Pharmaceutical Industries agreed to acquire Organon for $14 per share in cash, at an enterprise value of $11.75 billion, in the largest overseas acquisition by an Indian pharmaceutical company to date. The offer represents a 103% premium to the unaffected Organon share price of April 9, 2026, before deal speculation, and approximately 24% over the last close before announcement. Against $6.2 billion of FY2025 revenue and $1.9 billion of adjusted EBITDA, the enterprise value implies approximately 6x EV/EBITDA. Equity value is approximately $4 billion and Sun Pharmaceutical Industries assumes approximately $8.6 billion of gross debt (approximatively $8.0 billion of net debt), so a 103% equity premium coincides with a single-digit entry multiple, and the return on the transaction depends on the cash generation of Organon and on deleveraging rather than on multiple expansion. This transaction is the exception among the three major M&A deals. Sun Pharmaceutical Industries is buying commercial scale rather than capability, and the Organon biosimilars business rests on the Organon partnership with Samsung Bioepis, so Sun Pharmaceutical Industries acquires a licensing dependency rather than removing one. Sun Pharmaceutical Industries expects the combined group to hold approximately the seventh-largest biosimilar position worldwide, alongside women’s health and branded generics. Closing is expected in early 2027, subject to Organon shareholder approval and customary regulatory clearances.
Licensing still remains the most common transaction structure by count. What has changed is the purpose it serves. Generics companies are internalizing the development and manufacturing capability they previously bought from dedicated developers and contract development and manufacturing organizations, and they continue to license the assets that give portfolio breadth and the agreements that give access to individual geographies.
The two agreements set out below illustrate how licensing can broaden portfolios and expand geographic reach:
Samsung Bioepis and Sandoz: On March 18 to 19, 2026, Samsung Bioepis and Sandoz signed a global license, development, and commercialization agreement covering up to five biosimilar candidates, led by SB36, a vedolizumab candidate referencing Takeda Pharmaceuticals’ Entyvio®. The agreement extends a relationship that already covers Pyzchiva® (ustekinumab) since 2023 and EPYSQLI® (eculizumab) in the Middle East and Africa since December 2025. The commercial objective matches the objective behind the Just-Evotec Biologics acquisition, which is to secure future pipeline and capability from a dedicated developer, and the agreement could take the Sandoz biosimilar portfolio to as many as 32 assets, the largest of any single company.
Deal Update as of October 2, 2026
Samsung Bioepis and Teva Pharmaceuticals: On October 1, 2026, Samsung Bioepis and Teva Pharmaceuticals expanded their partnership to up to six biosimilar candidates, starting with SB41 (benralizumab, referencing Fasenra®) and SB44 (canakinumab, referencing Ilaris®), with options on four additional assets. As part of this partnership, Samsung Bioepis will develop, register and manufacture the products, while Teva will commercialize them across the US, Europe, and Canada. Building on their existing EPYSQLI (eculizumab) and OPUVIZ® (aflibercept) collaboration, the deal follows the same model as Samsung Bioepis and Sandoz above: a dedicated developer supplying a portfolio-level pipeline through a generics company’s commercial reach. SB41 and SB44 were disclosed for the first time and appear to be at an early, likely preclinical stage based on Samsung Bioepis’s Korean exchange filing.
Alvotech’s rest-of-world patent settlements: On January 29, 2026, Alvotech reached a global license and settlement with Regeneron Pharmaceuticals and Bayer, resolving the remaining ex-US patent disputes on the Alvotech aflibercept (Eylea® 2mg) biosimilar following an earlier US settlement. The settlement sets staggered launch dates of January 1, 2026, in the United Kingdom and Canada, May 1, 2026, across the European Economic Area and most other non-US markets, and November 1, 2026, in Japan for all indications. The settlement converts litigation risk into a dated launch schedule and clears the Alvotech regional partners, ADVANZ PHARMA, STADA, Biogaran, and Fuji Pharma Co., Ltd., to launch through the remainder of 2026.
Despite their prominence, these three major transactions are a small share of total biosimilar dealmaking by count. GlobalData recorded approximately 31 additional biosimilar-related transactions announced globally in the 12 months from July 2025 through June 2026. Licensing agreements and strategic partnerships accounted for 26 of the 31 transactions, and only five were acquisitions or asset transactions, all of them well below the scale of the three transactions reviewed.
Licensing remains the default structure for accessing individual assets and for entering individual geographies. Ownership is being used selectively, where the capability at stake is manufacturing capacity or a development platform that a company expects to use across a portfolio, and licensing continues wherever the requirement is a single asset or a single market.
Broadening the analysis across the full 12 months from July 2025 through June 2026 shows a wider range of licensing activity. Other notable transactions included the Fresenius Kabi agreement with Polpharma Biologics (August 2025), the STADA agreement with Bio-Thera Solutions (August 2025), the Sandoz agreement with EirGenix (November 2025), and the Teva Pharmaceuticals agreement with Prestige Biopharma (October 2025), alongside smaller regional commercialization agreements across the Middle East, Latin America, and Southeast Asia.
Deal Update as of October 2, 2026
Fresenius Kabi and mAbxience: On September 30, 2026, Fresenius Kabi completed the acquisition of the remaining 45% of mAbxience from Insud Pharma for up to €750 million, converting its majority stake acquired in 2022 into full ownership. Fresenius reported that mAbxience generated more than €320 million in 2025 revenue, with an EBITDA margin above Fresenius Kabi’s ~22.5%, making the acquisition directly margin-accretive.
Two of the three major deals focused on bringing development and manufacturing capability internally, while Sun Pharmaceuticals acquired commercial position with the third. Meanwhile, over 30 additional transactions focused primarily on licensing and partnerships. In all cases, companies are assessing their capabilities and strategic gaps and taking steps to adjust their market positioning.
At the same time, licensing and strategic partnerships continue to account for the majority of biosimilar transactions. The distinction appears to lie in what companies are trying to secure: ownership is being used where development platforms or manufacturing capacity can support multiple products over time, while licensing remains the more common route for accessing individual assets, expanding portfolios, or entering specific markets. The result is a deliberate division between the capabilities companies choose to own and those they continue to access through partners.
Alvotech. (2026, January 29). Alvotech secures settlement agreement in global markets for its biosimilar to Eylea® 2mg [Press release]. https://investors.alvotech.com/news-releases/news-release-details/alvotech-secures-settlement-agreement-global-markets-its
Amneal Pharmaceuticals, Inc. (2026, April 22). Amneal agrees to acquire Kashiv BioSciences to create global biosimilar leader [Press release]. https://investors.amneal.com/news/press-releases/press-release-details/2026/Amneal-Agrees-to-Acquire-Kashiv-BioSciences-to-Create-Global-Biosimilar-Leader-Reports-Strong-Preliminary-First-Quarter-2026-Financial-Results-and-Raises-FY2026-Standalone-Guidance/default.aspx
Evotec SE. (2025, December 8). Evotec closes sale of Just–Evotec Biologics’ Toulouse site to Sandoz [Press release]. https://www.evotec.com/news/evotec-closes-sale-of-just-evotec-biologics-toulouse-site-to-sandoz
GlobalData. (2026). Deals Advanced Data Export: Biosimilar-related transactions, July 2025–June 2026 [Proprietary database].
Insud Pharma. (2022, March 31). Insud Pharma and Fresenius Kabi combine efforts to accelerate the growth of mAbxience [Press release]. https://www.insudpharma.com/en/new/insud-pharma-and-fresenius-kabi-combine-efforts-to-accelerate-the-growth-of-mabxience/
Organon & Co. (2026, April 26). Sun Pharma signs definitive agreement to acquire Organon [Press release]. https://www.organon.com/news/sun-pharma-signs-definitive-agreement-to-acquire-organon/
Samsung Bioepis Co., Ltd. (2026, March 18). Samsung Bioepis enters into partnership agreement with Sandoz for up to five next-generation biosimilar candidates [Press release]. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=539
Teva Pharmaceutical Industries Ltd. (2026, October 1). Samsung Bioepis and Teva expand strategic partnership to advance up to six potential biosimilar candidates [Press release]. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Samsung-Bioepis-and-Teva-Expand-Strategic-Partnership-to-Advance-Up-to-Six-Potential-Biosimilar-Candidates/default.aspx