Global Biosimilar Companies You Must Know About

Global Biosimilar Companies You Must Know About

Biologic medicines changed modern healthcare. They treat complex diseases like cancer, autoimmune disorders, and diabetes. But they come with a problem: they are expensive.

That’s where biosimilars come in. A biosimilar is a medicine that is highly similar to an existing biologic drug. It delivers the same safety, quality, and clinical results. But it usually costs less.

Biologic drugs treat some of the world’s most serious diseases. But their price often limits access.  Nowadays, a lot of pharmaceutical companies are investing heavily in biosimilar development. In the next section, we’ll look at some of the top biosimilar companies in the world, and how they are helping make advanced therapies more accessible worldwide.

Top Biosimilar Companies in the World

The biosimilars market is growing fast. As patents for major biologic drugs expire, new companies are entering the space. Their goal is simple: make life-saving biologic treatments more affordable and widely available.

But, unlike generic drugs, biosimilars require advanced biologics research, complex manufacturing, and strict regulatory approval. Only a handful of companies have the technology and infrastructure to do this at scale.

Below are some of the top biosimilar companies in the world that are driving innovation, competition, and wider access to biologic medicines.

Novartis

Novartis is a global pharmaceutical leader and a major player in the biosimilars market. Its biosimilar business is mainly driven through Sandoz, a division focused on developing affordable biologic alternatives.

The company focuses on biosimilars for high-demand therapeutic areas, especially oncology and autoimmune diseases.

Key biosimilar products include:

• Zarxio: A biosimilar to Neupogen, used to reduce infection risk in cancer patients receiving chemotherapy.
• Erelzi: A biosimilar to Enbrel, used to treat autoimmune conditions like rheumatoid arthritis.
• Hyrimoz: A biosimilar to Humira, one of the world’s most widely used biologic drugs.

Novartis biosimilars are approved in major markets worldwide, including by the U.S. Food and Drug Administration and the European Medicines Agency.

With strong biologics expertise and global manufacturing capabilities, Novartis continues to play a key role in expanding access to affordable biologic therapies.

Pfizer

Pfizer is one of the largest pharmaceutical companies in the world and a key player in the global biosimilars market. The company has built a strong biosimilar portfolio focused on oncology, inflammation, and immunology therapies.

Pfizer develops biosimilars for some of the most widely used biologic drugs. Its strategy focuses on bringing high-quality, lower-cost alternatives to major healthcare markets.

Some of Pfizer’s notable biosimilars include:

• Zirabev: a biosimilar to Avastin, used for several types of cancer.
• Trazimera: a biosimilar to Herceptin, used to treat HER2-positive breast cancer.
• Inflectra: a biosimilar to Remicade, used for autoimmune diseases.

Pfizer’s biosimilars are approved in multiple regions, including the United States, Europe, and Asia. Many have received approvals from regulators like the U.S. Food and Drug Administration and the European Medicines Agency.

Through strategic partnerships, global manufacturing, and strong commercialization capabilities, Pfizer continues to expand its presence in the biosimilars market.

Catalent

Catalent is a leading contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Instead of selling its own biosimilars, the company helps other pharma companies develop, manufacture, and scale biologic and biosimilar drugs.

Catalent plays an important role behind the scenes in the biosimilars market. The company supports biosimilar development through:

• Biologics development services: Helping companies move biosimilar candidates from early development to clinical production.
• Large-scale manufacturing capabilities: Advanced biologics facilities that support commercial biosimilar production.
• Formulation and drug delivery expertise: Assisting companies in creating stable and effective biologic formulations.

By providing end-to-end development and manufacturing services, Catalent enables pharmaceutical companies to bring biosimilars to market faster and at scale. This makes it an important partner in the global biosimilars ecosystem.

Amgen

Amgen is a pioneer in biologic medicines and one of the most influential companies in the biosimilars market. With decades of biologics expertise, Amgen develops biosimilars that target high-demand therapies in oncology and immunology.

The company focuses on producing high-quality biosimilars that match the safety and effectiveness of original biologic drugs.

Key biosimilar products from Amgen include:

• Amjevita: a biosimilar to Humira, used to treat autoimmune diseases.
• Mvasi: a biosimilar to Avastin, used in several cancer treatments.
• Kanjinti: a biosimilar to Herceptin, used for HER2-positive breast cancer.

Amgen’s biosimilars are approved in major pharmaceutical markets, including the United States, Europe, and Asia, with regulatory clearances from agencies such as the U.S. Food and Drug Administration and the European Medicines Agency.

With strong R&D capabilities, global manufacturing infrastructure, and a growing biosimilar portfolio, Amgen continues to be a key leader in the global biosimilars industry.

Biogen

Biogen is a global biotechnology company known for its expertise in biologic medicines. While the company is best known for its work in neurology, it has also played an important role in the biosimilars market through strategic partnerships.

Biogen has focused on collaborative biosimilar development, working with other pharmaceutical companies to bring biosimilars to global markets.

Key aspects of Biogen’s biosimilar strategy include:

• Strategic partnerships: Collaboration with companies like Samsung Bioepis to develop and commercialize biosimilars.
• Commercialization support: Helping expand biosimilar access in key markets such as Europe and North America.
• Biologics expertise: Leveraging decades of biologics research and regulatory experience.

Biogen’s biosimilar activities mainly focus on oncology and immunology therapies, where biologic drugs play a major role in treatment. Through partnerships and global commercialization efforts, Biogen continues to contribute to the growth of the biosimilars market worldwide.

Patheon

Patheon is a global contract development and manufacturing organization (CDMO) that supports pharmaceutical companies in developing and producing biologics and biosimilars. The company operates as part of Thermo Fisher Scientific, one of the largest life sciences companies in the world.

Patheon helps pharmaceutical companies move biosimilars from early development to large-scale commercial production.

Key capabilities include:

• Biologics development services: Supporting biosimilar drug development, formulation, and clinical manufacturing.
• Commercial-scale manufacturing: Large biologics facilities designed to produce complex biosimilar medicines.
• Regulatory and technical expertise: Helping companies navigate strict biologics manufacturing and approval requirements.

Patheon operates multiple manufacturing and development sites worldwide, supporting pharmaceutical companies across North America, Europe, and Asia. With strong infrastructure and biologics expertise, Patheon plays a critical role in enabling companies to bring biosimilars to global markets efficiently.

Shanghai Henlius Biotech

Shanghai Henlius Biotech is a China-based biopharmaceutical company focused on biosimilar development and biologic innovation. The company specializes in creating affordable alternatives to major biologic drugs used in oncology and autoimmune diseases.

Henlius has built a strong biosimilar portfolio targeting high-demand biologic therapies.

Notable biosimilar products include:

• Hanlikang: A biosimilar to Rituxan, used for treating certain cancers and autoimmune diseases.
• Zercepac: A biosimilar to Herceptin, used in HER2-positive breast cancer treatment.

The company has received approvals in China and several international markets, and continues to expand globally through regulatory filings and partnerships. With strong R&D investment and growing international presence, Shanghai Henlius Biotech is emerging as an important player in the global biosimilars industry.

Viatris

Viatris is a global healthcare company formed through the merger of Mylan and Upjohn, a former division of Pfizer. The company focuses on expanding access to affordable medicines, including biosimilars.

Viatris has built a growing biosimilar portfolio targeting oncology and immunology treatments. Key biosimilar products include:

• Ogivri: A biosimilar to Herceptin, used to treat HER2-positive breast cancer.
• Fulphila: A biosimilar to Neulasta, used to reduce infection risk in chemotherapy patients.

Viatris develops biosimilars through strategic partnerships, including collaborations with companies like Biocon Biologics.

With a strong global distribution network and presence in more than 165 countries, Viatris plays an important role in expanding global access to biosimilar therapies.

Celltrion

Celltrion is a South Korea–based biopharmaceutical company and one of the global leaders in biosimilar development. The company focuses on producing high-quality biosimilars for major biologic drugs used in oncology and autoimmune diseases.

Celltrion is known for launching some of the earliest monoclonal antibody biosimilars in global markets.

Key biosimilar products include:

• Remsima: A biosimilar to Remicade, used to treat autoimmune diseases.
• Truxima: A biosimilar to Rituxan, used in cancer and autoimmune therapies.
• Herzuma: A biosimilar to Herceptin, used for HER2-positive breast cancer.

Celltrion’s biosimilars have received approvals from regulators like the U.S. Food and Drug Administration and the European Medicines Agency.

With strong manufacturing capabilities and growing global partnerships, Celltrion continues expanding its presence across Europe, Asia, and North America.

Samsung Bioepis

Samsung Bioepis is a biopharmaceutical company focused on developing and commercializing biosimilars. It was established as a joint venture between Samsung Biologics and Biogen to expand the global biosimilars market.

The company develops biosimilars for major biologic drugs used in oncology, immunology, and autoimmune diseases.

Key biosimilar products include:

• Benepali: A biosimilar to Enbrel, used for autoimmune diseases.
• Ontruzant: A biosimilar to Herceptin, used to treat HER2-positive breast cancer.
• Imraldi: A biosimilar to Humira, used for inflammatory conditions.

Samsung Bioepis biosimilars are approved in major pharmaceutical markets, including Europe, the United States, and Asia. Many have received approvals from regulators such as the U.S. Food and Drug Administration and the European Medicines Agency.

With strong biologics expertise and global partnerships, Samsung Bioepis has become a key player in the global biosimilars industry.

Conclusion

Biosimilars are helping make biologic medicines more affordable and accessible worldwide. Leading companies such as Novartis, Pfizer, Amgen, and Celltrion continue to drive innovation and expand biosimilar availability across major global markets.

As more biologic drug patents expire, competition in the biosimilars sector is expected to grow. This will likely lead to more biosimilar launches, lower treatment costs, and wider patient access to advanced biologic therapies in the years ahead.

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