Top Biosimilars Companies 2025

As patents for key biologic drugs continue to expire, leading pharmaceutical and biotechnology companies are driving innovation, competition, and accessibility through biosimilar development. These biosimilars—highly similar versions of approved biologic medicines—offer significant opportunities to improve patient access and reduce healthcare costs. The following overview highlights major global players in the biosimilar market, their backgrounds, and their strategic contributions to advancing this field.

1. Sandoz Group AG

Sandoz Group AG, headquartered in Switzerland, is a global leader in generic pharmaceuticals and biosimilars. Originally part of Novartis, Sandoz became an independent entity in 2023, continuing its legacy of making high-quality medicines accessible and affordable worldwide.

In the biosimilar market, Sandoz is considered a pioneer, having launched the world’s first biosimilar in 2006. It has one of the broadest biosimilar portfolios, including products for oncology, immunology, and endocrinology. The company continues to invest heavily in R&D and manufacturing to expand its biosimilar pipeline globally.

2. Pfizer Inc.

Pfizer Inc. is a U.S.-based multinational biopharmaceutical company known for its innovation in vaccines, oncology, and chronic disease treatments. With a history spanning over 170 years, Pfizer is one of the world’s largest pharmaceutical companies with a strong focus on R&D and global health access.

In biosimilars, Pfizer has established a robust presence through its Pfizer Biosimilars division. It markets biosimilars in key therapeutic areas such as oncology, inflammation, and supportive care, including products like Inflectra (infliximab) and Retacrit (epoetin alfa). Pfizer is leveraging its biologics expertise to strengthen its competitive edge in this growing market.

3. Amgen Inc.

Amgen Inc., based in California, is one of the world’s leading biotechnology companies, renowned for its biologic innovations in oncology, nephrology, and cardiovascular diseases. Since its founding in 1980, Amgen has been a pioneer in using advanced science and biotechnology to deliver transformative therapies.

Amgen plays a dual role in the biosimilar market—as both an originator and biosimilar developer. The company has launched several biosimilars, such as Mvasi (bevacizumab) and Kanjinti (trastuzumab), targeting blockbuster biologics. Its deep biologics expertise and global manufacturing capacity position it as a key competitor in the biosimilar arena.

4. Celltrion Inc.

Celltrion Inc., headquartered in South Korea, is a biopharmaceutical company specializing in monoclonal antibody-based therapeutics. The company is known for its strong biomanufacturing capabilities and focus on global healthcare solutions.

Celltrion is one of the earliest and most successful players in the biosimilar market, producing world-leading biosimilars such as Remsima (infliximab) and Truxima (rituximab). Its strategy centers on expanding biosimilar adoption globally, particularly in regulated markets such as the U.S. and Europe, while continuously developing next-generation biosimilars.

5. Biocon Ltd.

Biocon Ltd., based in India, is a leading biopharmaceutical company focused on diabetes, oncology, and immunology. It has grown from an enzyme manufacturing firm into one of Asia’s largest biotechnology companies, with a strong global presence.

Through its subsidiary Biocon Biologics, Biocon is a major player in the biosimilar sector. It has developed and commercialized multiple biosimilars in partnership with Viatris, including trastuzumab, insulin glargine, and pegfilgrastim. The company aims to democratize access to high-quality biologics through cost-effective biosimilar solutions worldwide.

6. Dr. Reddy’s Laboratories Ltd.

Dr. Reddy’s Laboratories Ltd., headquartered in Hyderabad, India, is a multinational pharmaceutical company that develops generics, branded formulations, and active pharmaceutical ingredients. It focuses on affordable healthcare and innovation.

In the biosimilar market, Dr. Reddy’s has developed a diverse portfolio in oncology and autoimmune diseases, including products like rituximab and pegfilgrastim biosimilars. The company continues to expand its biosimilar pipeline and global footprint, especially in emerging and semi-regulated markets.

7. Eli Lilly and Company

Eli Lilly and Company, based in the United States, is a global pharmaceutical leader focused on diabetes, oncology, immunology, and neuroscience. Founded in 1876, Lilly is recognized for its pioneering work in insulin and biologic innovations.

While primarily a biologics innovator, Lilly has entered the biosimilar space through partnerships and in-house development. It markets insulin biosimilars, including Basaglar (insulin glargine), competing directly with established biologics to increase access and affordability for patients with diabetes.

8. Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is one of the world’s largest generic drug manufacturers. It provides a wide range of generic, specialty, and over-the-counter products across global markets.

Teva is expanding its biosimilar portfolio through strategic alliances, particularly with companies like Alvotech. Its focus areas include oncology, immunology, and central nervous system disorders. By leveraging its distribution strength, Teva aims to increase biosimilar availability worldwide.

9. Fresenius Kabi AG

Fresenius Kabi AG, a German healthcare company, specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. It is part of the Fresenius Group, a global healthcare conglomerate.

Fresenius Kabi has been actively building its biosimilars portfolio, focusing on oncology and autoimmune indications. Its biosimilar business complements its hospital and infusion expertise, enabling it to provide integrated care solutions globally.

10. STADA Arzneimittel AG

STADA Arzneimittel AG, based in Germany, is a global pharmaceutical company focused on generics, consumer healthcare products, and specialty pharmaceuticals. It operates in more than 120 countries.

STADA is a growing player in the biosimilar market through partnerships and product acquisitions. It markets biosimilars in areas like oncology and immunology and aims to expand access to cost-effective biologics across Europe and emerging regions.

11. Boehringer Ingelheim International GmbH

Boehringer Ingelheim, headquartered in Germany, is one of the largest privately held pharmaceutical companies in the world. It focuses on human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is both an originator and a biosimilar producer. Its biosimilar portfolio includes Cyltezo (adalimumab), the first interchangeable Humira biosimilar approved in the U.S. The company also offers contract manufacturing services for other biosimilar developers through its BioXcellence division.

12. Samsung Biologics

Samsung Biologics, based in South Korea, is a global leader in biopharmaceutical manufacturing and contract development. It offers end-to-end biomanufacturing services, including cell line development and large-scale production.

Through its affiliate Samsung Bioepis, the company has become a major force in the biosimilar market. Samsung Bioepis has launched biosimilars for key biologics such as Enbrel, Humira, and Remicade, expanding access to biologic therapies globally.

13. Amneal Pharmaceuticals LLC

Amneal Pharmaceuticals LLC, headquartered in the United States, is a diversified pharmaceutical company specializing in generics, specialty medicines, and biosimilars. It focuses on affordable healthcare solutions through innovation and quality.

Amneal has entered the biosimilar market to complement its strong generics base. It is developing and commercializing biosimilars in partnership with leading biotech firms, focusing on oncology and immunology therapies to expand its specialty portfolio.

14. Coherus BioSciences

Coherus BioSciences, based in California, is a biopharmaceutical company focused on biosimilars and immuno-oncology. It aims to improve patient access to biologics through high-quality, affordable alternatives.

Coherus has established itself as a leading biosimilar company in the U.S., with products such as Udenyca (pegfilgrastim) and Yusimry (adalimumab). The company continues to build its biosimilar and immuno-oncology pipeline to strengthen its long-term market presence.

15. Bio-Thera Solutions

Bio-Thera Solutions, based in China, is a biotechnology company engaged in the discovery, development, and manufacturing of innovative therapeutics and biosimilars. It has strong capabilities in monoclonal antibody production.

Bio-Thera has developed several biosimilars approved in China and globally, including BAT1406 (adalimumab) and BAT1706 (bevacizumab). The company’s goal is to expand its biosimilar portfolio internationally while advancing novel biologics for cancer and autoimmune diseases.

16. Aprogen

Aprogen, headquartered in South Korea, is a biopharmaceutical company specializing in protein engineering and antibody-based therapeutics. It has been involved in biopharmaceutical R&D since the early 2000s.

Aprogen plays a strategic role in biosimilar development through collaborations with global partners. It has focused on monoclonal antibody biosimilars such as infliximab and rituximab, contributing to South Korea’s position as a leading biosimilar hub.

17. Shanghai Henlius Biotech, Inc.

Shanghai Henlius Biotech, Inc. is a China-based biopharmaceutical company dedicated to developing biologics and biosimilars in oncology, autoimmune, and ophthalmic diseases. It is known for its strong in-house R&D and manufacturing platforms.

Henlius is one of China’s foremost biosimilar developers, with products such as Hanlikang (rituximab) and Zercepac (trastuzumab). The company is expanding globally through partnerships and regulatory approvals in Europe and emerging markets.

Collectively, these companies represent the backbone of the global biosimilar industry, shaping its growth through innovation, collaboration, and large-scale manufacturing capabilities. Their efforts are expanding patient access to advanced biologic therapies and fostering a more sustainable healthcare ecosystem. As regulatory frameworks mature and market acceptance increases, the biosimilar sector is poised for continued growth, with these key players leading the charge toward a more affordable and equitable future in biopharmaceuticals.