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Biosimilar Deal Landscape: M&A, Licensing Trends, and Market-Shaping Partnerships
Chapter of the 2025 Global Biosimilars Report
12 minute read
Strategic partnerships and mergers and acquisitions (M&A) have significantly shaped the biosimilar industry, with deal activity peaking in 2021 and 2022. Generic drug manufacturers have increasingly participated in deals, reflecting their growing interest in the biosimilar market.
As illustrated by the complex partnering and acquisition strategies of the market leaders, licensing agreements, joint ventures, and M&A have played a pivotal role in shaping the broader biosimilar industry.
Despite fluctuations over time, there has been a constant flow of both M&A and licensing deals since 2015. Deal activity peaked in 2021 and 2022, with 23 licensing deals and eight acquisitions per year, respectively.
This article examines major licensing and M&A trends that have defined the biosimilar market and examines such major deals as Pfizer – Hospira, Viatris – Biocon Biologics, Fresenius Kabi – Merck and Mabxience, and Formycon.
Licensing
Licensing has been the most common form of partnering due to the lower associated financial commitment and risk for the licensor compared to acquisitions. While licensing allows large pharmaceutical and generics companies to bolster their biosimilar portfolio or to expand into the biosimilar market for the first time, smaller companies focused on research and development (R&D) can benefit from access to global markets and commercialization expertise. The associated upfront and milestone payments allow smaller R&D-focused companies to de-risk the development cost and alleviate the financial burden.
Sources: Global Data; Alira Health analysis
Pharmaceutical companies were licensees in 71% of all licensing agreements from 2015 to 2018. Over time, generics pharmaceutical companies that traditionally focus on small molecules have gained greater importance as licensing partners, with their share increasing to 50% of all licensing deals since 2023. This shift correlates with the increasing interest of generics companies in the biosimilar field as the market matures. As smaller R&D-focused companies pioneered the R&D of biosimilars, they continue to act predominantly as licensors in these deals. Alvotech has been the most active dealmaker with 18 deals since 2015. Other frequent licensors include Shanghai Henlius Biotech (13), Bio-Thera Solutions (12), Samsung Bioepis (11), Rani Therapeutics (9), Similis Bio (8), Momenta Pharmaceuticals (7), and Prestige BioPharma (6). |
Sources: Global Data; Alira Health analysis |
Pharmaceutical companies were licensees in 71% of all licensing agreements from 2015 to 2018. Over time, generics pharmaceutical companies that traditionally focus on small molecules have gained greater importance as licensing partners, with their share increasing to 50% of all licensing deals since 2023. This shift correlates with the increasing interest of generics companies in the biosimilar field as the market matures.
As smaller R&D-focused companies pioneered the R&D of biosimilars, they continue to act predominantly as licensors in these deals. Alvotech has been the most active dealmaker with 18 deals since 2015. Other frequent licensors include Shanghai Henlius Biotech (13), Bio-Thera Solutions (12), Samsung Bioepis (11), Rani Therapeutics (9), Similis Bio (8), Momenta Pharmaceuticals (7), and Prestige BioPharma (6).
Sources: Global Data; Alira Health analysis
Looking at the development stage of the assets at the time of licensing, the distribution has been relatively stable until recently, with the majority of licensed molecules approved or already marketed: Commercial assets were 65% in 2015–2018 and 67% in 2019–2022, then eased to 54% in 2023–2024 as more pipeline assets entered licensing. Molecules in clinical development fluctuated around 15–17% historically, rising to 28% in 2023–2024. Discovery & preclinical assets have remained steady at about 18%, indicating that roughly one in five licensed molecules had not yet started clinical development at the time of the deal.
Sources: Global Data; Alira Health analysis
M&A
While less prevalent than licensing deals, M&A has been and remains an important cornerstone in the strategy of biosimilar players. We see both asset transactions concerning individual biosimilars or a portfolio of biosimilars and transactions that are structured as share deals and include R&D capabilities. Companies often create joint ventures to either partner for specific development programs or to carve out an existing biosimilar business from a company’s core business and operate it as a standalone business unit.
M&A activity has historically been led by pharmaceutical companies. In 2015–2018, pharma accounted for 78% of acquirers. Similar to the increasing relevance of generics companies in licensing agreements, 2023–2024 shows a marked shift, with generics companies responsible for 67% of all acquisitions.
Sources: Global Data; Alira Health analysis
In contrast to licensing deals in which we see the role of generics companies increasing over time, in M&A activity, the split by type of acquirer has remained relatively constant from 2015 to 2023. Throughout, generics companies have accounted for 17–18% of deals.
For pharmaceutical companies and generics companies interested in entering the biosimilar space, initiating a biosimilar development program internally translates to high development costs and risks, while requiring a long time to market. In those instances, acquisitions have often been a viable way to access late-stage or approved biosimilar development programs with shorter time to market while significantly derisking regulatory and development risks.
For acquirers, the motivation for acquisitions falls broadly into three categories:
- Access to products
- R&D and manufacturing capabilities
- Commercial reach (in few cases)
Sources: Global Data; Alira Health analysis
Access to products has been the primary rationale driving acquisitions in the biosimilar space. However, there are slight differences in the acquisitive behavior depending on the type of acquirer. Specifically, if acquirers lack existing R&D capabilities and experience with biologics prior to the acquisition, internalizing new R&D talent and expertise is critical in building a sustainable development pipeline in the long term.
While the M&A deal volume is still relatively low compared to other, more mature industry verticals, the biosimilar space has already seen several landmark deals.
Sources: Global Data; Alira Health analysis
Pfizer – Hospira
Pfizer’s acquisition of Hospira in 2015 is the largest deal in the biosimilar space so far, with a deal value of $16.1 billion. The acquisition marked Pfizer’s entry in the biosimilar market and brought a robust pipeline of biosimilars, including approved products like Inflectra® (a biosimilar to Remicade), along with extensive experience in biosimilar development, manufacturing, and regulatory processes. This acquisition allowed Pfizer to expand its biosimilar portfolio quickly, enhance its manufacturing capabilities, and gain a competitive edge in providing affordable biologics alternatives in key global markets.
Viatris – Biocon Biologics
As part of Viatris’ strategy to focus on its more established generics business, it divested its global biosimilars business to Biocon Biologics for $3.0 billion in 2022. This acquisition included Viatris’ global biosimilars portfolio, its commercial capabilities, and rights to a pipeline of biosimilars under development. The deal allowed Biocon to gain full ownership and commercialization rights to several approved biosimilar products, including insulin glargine, trastuzumab, and bevacizumab, and provided access to Viatris’ biosimilars manufacturing and commercialization infrastructure. This represented a transformational acquisition for Biocon Biologics that significantly expanded its product portfolio and market reach.
Formycon
In 2022, Formycon acquired all rights to the ranibizumab and ustekinumab biosimilars, as well as the bioeq development unit that was owned by the ATHOS family office, through a capital increase and asset contribution in kind valued at $713.2 million. The transaction strengthened Formycon’s position as an integrated biosimilar company and saw the ATHOS family office become its largest individual shareholder.
Fresenius Kabi – Merck
As part of Fresenius Kabi’s strategy to enter the biosimilar market and strengthen its position, it has executed two significant acquisitions. In 2017, Fresenius Kabi acquired Merck’s biosimilar business, including Merck’s biosimilar pipeline and development capabilities. This transaction laid the foundation for Fresenius Kabi’s entry into the biosimilar market.
Fresenius Kabi – Mabxience
In 2022, Fresenius further expanded its biosimilar presence by acquiring a majority stake in Mabxience, a leading global biosimilars company. This acquisition provided Fresenius with additional biosimilar products and development and manufacturing capabilities. This deal also expanded its global footprint, particularly in emerging markets.