Top 10 Companies Leading the Global Biosimilars Market

Biologics has transformed the treatment of severe conditions such as cancer, diabetes, and autoimmune diseases. However, their high costs continue to limit access for many patients globally.

This is where biosimilars come into play. They provide more affordable yet highly effective alternatives once the original biologic's patent expires. These therapies help reduce treatment costs while maintaining comparable safety, quality, and efficacy.

According to BCC Research, the global biosimilars market was valued at $23.8 billion in 2023 and is expected to grow from $28.5 billion in 2024 to $69.2 billion by 2029, with a compound annual growth rate (CAGR) of 19.4%. This growth is being driven by an increasing demand for cost-effective therapies and a wave of patent expirations for biologics.

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As healthcare systems worldwide strive to balance innovation with affordability, biosimilars are becoming an essential part of that solution. Here are 10 leading companies that are shaping the future of the global biosimilars market.

Pfizer Inc.

Headquarters: New York, USA | Founded: 1849

Pfizer entered the biosimilars market with the strength of its global infrastructure and clinical expertise. The company has launched biosimilars in over 70 countries, featuring key products such as Inflectra (infliximab) and Retacrit (epoetin alfa). Known for its extensive portfolio in oncology, inflammation, and supportive care, Pfizer has made substantial investments in post-marketing surveillance and education to foster physician trust in biosimilars.

Amgen Inc.

Headquarters: California, USA | Founded: 1980

Amgen is a leading global biotechnology company with a robust pipeline of biosimilars. Its approved products include Mvasi (a biosimilar to Avastin), Kanjinti (a biosimilar to Herceptin), and Amgevita (a biosimilar to Humira). Operating in over 100 countries, Amgen has invested billions in the development of biosimilars and continues to expand its global presence in oncology and immunology.

3. Samsung Bioepis

Headquarters: Incheon, South Korea | Founded: 2012

A joint venture between Samsung and Biogen, Samsung Bioepis is known for its speed in development and regulatory filings. It became the first Korean company to enter the EU biosimilars market. Products such as Ontruzant (trastuzumab) and Renflexis (infliximab) have gained significant traction in Europe. Additionally, Samsung Bioepis is expanding its portfolio to include treatments for ophthalmology and autoimmune diseases. Their products are available in Europe, Asia, the U.S., and other regions.

4. Sandoz

Headquarters: Basel, Switzerland | Founded: 1886

Sandoz is a leader in the biosimilar market, launching Europe’s first biosimilar, Omnitrope, in 2006. The company offers a diverse portfolio of biosimilars, including Zarxio, Erelzi, and Hyrimoz, which target various therapeutic areas such as oncology, immunology, and endocrinology. Recently, Sandoz announced plans to operate as an independent publicly traded company, demonstrating its commitment to focusing on biosimilars as a core aspect of its business.

5. Biocon Biologics

Headquarters: Bengaluru, India | Founded: 1978

Biocon Biologics has positioned itself as a cost-efficient manufacturing leader with a strong R&D backbone. In partnership with Viatris, it co-developed Semglee, the first interchangeable insulin biosimilar approved in the U.S. Recently, Biocon acquired Viatris's biosimilars business, granting it direct commercialization rights in developed markets such as the U.S. and Europe, marking a shift from a B2B to a B2C model.

6. Celltrion Healthcare

Headquarters: Incheon, South Korea | Founded: 2002

Celltrion made history by becoming the first company to receive FDA approval for a monoclonal antibody biosimilar. Its flagship products include Remsima (infliximab), Truxima (rituximab), and Herzuma (trastuzumab). The company is also developing self-injectable biosimilar devices and plans to distribute in-house in the U.S., indicating a move toward vertical integration. Additionally, Celltrion exports to over 110 countries.

7. Coherus BioSciences

Headquarters: California, USA | Founded: 2010

As a biosimilars-focused biotech, Coherus gained attention with Udenyca (pegfilgrastim), which achieved over 20% market share in the U.S. within the first year. Recently, Coherus expanded its portfolio by introducing Cimerli (ranibizumab), the first and only interchangeable biosimilar to Lucentis. It partnered with Junshi Biosciences to introduce toripalimab, a PD-1 checkpoint inhibitor, to the U.S., marking its expansion beyond biosimilars into immuno-oncology.

8. Boehringer Ingelheim

Headquarters: Ingelheim, Germany | Founded: 1885

Boehringer entered the biosimilars market with a focus on interchangeability, becoming the first company to receive FDA approval for Cyltezo, an interchangeable Humira biosimilar. Although its portfolio is smaller, the company is committed to long-term investments in immunology and biologics, with plans to expand production capacity in Europe and the U.S. It operates in over 100 countries.

9. Fresenius Kabi

Headquarters: Bad Homburg, Germany | Founded: 1912

Fresenius Kabi acquired Merck KGaA’s biosimilars pipeline and launched Idacio (adalimumab) in Europe. The company is recognized for its robust hospital network and distribution channels. It is leveraging its global infrastructure to expand access to biosimilars in Latin America, Asia-Pacific, and Europe. Additionally, Fresenius Kabi is developing biosimilars focused on oncology and nephrology.

10. Viatris Inc.

Headquarters: Pennsylvania, USA | Founded: 2020

Viatris was formed by the merger of Mylan and Pfizer’s Upjohn division and has become one of the most widely distributed biosimilar companies, operating in over 165 countries. The company co-developed biosimilars such as Ogivri, Fulphila, and Semglee in partnership with Biocon Biologics. In 2023, Viatris announced a strategic shift, divesting its biosimilar division to Biocon while focusing on its core markets in generics and specialty medicines.

Conclusion

As patents for blockbuster biologics expire, the global biosimilars market is undergoing a transformative phase. This change is driven by companies that are leveraging innovation, scalability, and global strategies to meet the increasing demand for biosimilars. With the market projected to rise to $69.2 billion by 2029, biosimilars are no longer just affordable alternatives; they’re becoming essential tools for expanding access to treatments, reducing healthcare costs, and shaping the future of biologic care.

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