Top 4 Leading Biosimilar Companies to Watch in 2025

Published: March 2025

Owing to the increased prevalence rate of chronic diseases and the need for cost-effective advanced therapies, several researchers and industry stakeholders are increasingly shifting their focus towards the development of biosimilars. We analyzed more than 900 biosimilars marketed / currently under investigation, developed by more than 170 developers engaged in this domain. In this article, discover the top biosimilar companies and their portfolio related to biosimilars market.

Biosimilars are highly similar versions, with no clinically meaningful difference from the innovator biologic. The increasing need for cost-effective and easily accessible healthcare solutions has underscored the importance of biosimilars, which serve as an affordable alternative to the expensive reference biologic therapies. Biosimilars offer equivalent efficacy, quality, and safety as the innovator biologic product, broadening patient access to life-saving treatments for chronic and complex diseases. They promote competition and innovation within the pharmaceutical industry, driving down costs and easing financial pressures on the healthcare systems. By offering substantial savings without compromising on the therapeutic outcomes, biosimilars play a crucial role in ensuring sustainable and equitable healthcare for patients worldwide.

Further, a number of blockbuster biologics patents are anticipated to go off patent in the foreseen future, paving the way for various players to research, develop and commercialize the biosimilar products for different biologic targets. Additionally, the improved analytical tools are expected to enhance the ability to characterize complex biologic molecules. Coupled with continuous advancements in integrating innovative technologies with the manufacturing processes are expected to result in efficient and consistent production of biosimilars.

Roots Analysis has conducted an exhaustive study on Global Biosimilars Market featuring the current biosimilars market landscape and future opportunity for the drug developers that are engaged in the biosimilars industry, over a span of 10 years.

The top 4 biosimilar developers are listed below along with the information on the year of establishment and location of headquarters are listed below (in alphabetical order):

Table 1: List of Top Four Biosimilar Companies

S. No.	Company	Year of Establishment	Location of Headquarters (Country)	Location of Headquarters
1	Amgen	1980	California, US	North America
2	Pfizer	1849	New York, US	North America
3	Sandoz	1886	Basel, Switzerland	Europe
4	Celltrion	2002	Incheon, South Korea	Asia-Pacific

Interested in exploring 900+ marketed and developmental stage biosimilars and more than 170 biosimilar companies?

Discover Below the Details on Top Four Biosimilar Companies

Let us deep dive to understand the activity of the top four biosimilar companies (based on general understanding) in the global biosimilars market. It is essential to note that the selection of top biosimilar developers can differ substantially according to the defined criteria.

**Amgen Invested More than USD 2 billion Across a Portfolio of More Than 10 Biosimilars (either approved or currently under development)**

1. Amgen

Amgen focuses on the development, manufacturing, and delivery of novel human therapeutics targeting various disease indications, including autoimmune disorders, cardiovascular disorders, respiratory disorders and oncological disorders. The company aims to advance human genetics by unravelling the complexities of disease and understanding the mechanism of human biology. Further, the company claims to have established its footprint in around 100 countries and regions worldwide.

Amgen has a successful biosimilars business, with 8 approved products across rare disease, inflammation and oncology segments. As stated by the company at an investor presentation at the 43rd Annual J.P. Morgan Healthcare Conference, Amgen biosimilars have together generated cumulative sales of USD 10 billion through Q3 2024.

Amgen: Company Overview

Key Parameters	Description
Company Logo
Year of Establishment	1980
Number of Employees	10,001+
Headquarters	US

Short-term Plans and Future Outlook:

PAVBLU (aflibercept biosimilar) and Wezlana (Ustekinumab biosimilar) launch is underway in the US.
Bekemv / Bkemv (eculizumab biosimilar) launch planned in the US in Q2 2025.
Read out of phase III results for ABP 206 (Opdivo biosimilar) is planned in H2 2025.

The company stands to launch and file approvals for additional biosimilars in order to meet the evolving needs of its customers and to distinguish itself from the competitors in this domain.

Further details on recent initiatives taken by Amgen and other biosimilar companies have been provided in detail in the report.

Pfizer With a Portfolio of 8 Approved Biosimilars, is Facing Declining Revenues from Oncology Biosimilars Driven by Lower Net Price in the US

2. Pfizer

Pfizer, with a history spanning over 175 years, has established itself as a pioneer in wellness, prevention, and treatment across a broad range of therapeutic areas. The company’s comprehensive portfolio encompasses medicines, vaccines, and consumer healthcare products that target some of the most formidable diseases, including neurological and oncological disorders. Additionally, it has a robust pipeline of promising novel products and an industry-leading portfolio of over 25 approved oncology medications and biosimilars across over 40 indications.

For full year 2024, the company reported unaudited revenues of USD 1,037 billion from oncology biosimilars (Retacrit, Ruxience, Zirabev, Trazimera and Nivestym), a decline of 26% over the previous year. This was primarily attributed to a lower net price in the US and supply constraints for certain products.

Pfizer: Company Overview

Key Parameters	Description
Company Logo
Year of Establishment	1849
Number of Employees	10,001+
Headquarters	US

The company signed a biosimilars manufacturing agreement with Samsung Biologics in order to provide the former company with additional capacity for large-scale manufacturing of its multi-product biosimilars portfolio and expected to pursue additional strategic partnerships to further expand its manufacturing capabilities.

Further details on recent initiatives taken by Pfizer and other biosimilar companies have been provided in detail in the report.

Sandoz Has a Deep Biosimilar Pipeline With 28 Products Under Development; Expanding Production Capacity to Meet the Demand

3. Sandoz

Sandoz, a division of Novartis, is a global provider of off-patent medicines. The company comprises a portfolio of approximately 1,500 high-quality generic and biosimilars medicines, serving over 800 million patients annually across more than 100 countries. By developing affordable, high-quality alternatives to original medicines once patents expire, the firm creates competition in the market, thereby improving healthcare accessibility.

Sandoz: Company Overview

Key Parameters	Description
Company Logo
Year of Establishment	1886
Number of Employees	10,001+
Headquarters	Switzerland

The company expanded its capabilities through the establishment of a biosimilar development centre in Holzkirchen, Germany and is expected to continue to expand its operations in order to accelerate the development of biosimilars.

Short-term Plans and Future Outlook:

Pyzchiva (Ustekinumab) launch planned in the US in Q1 2025.
Wyost® / Jubbonti (denosumab) launch planned in the US in Q2 2025.
The company is building a biosimilar manufacturing site in Slovenia Sandoz Biopharma Development Center is planned to be operation by 2026.

Further details on recent initiatives taken by Sandoz and other biosimilar companies have been provided in detail in the report.

With a Target to Commercialize 22 Biosimilars by 2030 and a Plan for European Expansion, Celltrion is Entering into Partnerships and Collaborations

4. Celltrion

Celltrion specializes in the research, development, and manufacturing of innovative therapeutics. As a pioneer in biotherapeutic development, the company has introduced a new paradigm to the global biologics market by unveiling the world's first monoclonal antibody biosimilar. With extensive clinical trial experience and regulatory expertise, it has secured sales approvals for its biosimilars in nearly 100 countries, including multiple approvals from the FDA and the EMA. Notably, the firm claims to be Korea's largest manufacturer and exporter of biosimilars, boasting an annual production capacity of 250,000 liters.

Celltrion: Company Overview

Key Parameters	Description
Company Logo
Year of Establishment	2002
Number of Employees	1,001-5,000
Headquarters	South Korea

Recently, the firm received approval from the EC for SteQeyma (CT-P43) for the treatment of multiple chronic inflammatory diseases. Along with this, the company announced its FDA-approved biosimilar candidate, adalimumab-aaty, has been added to the Costco member prescription program. Further, the increased approval and launch of biosimilars highlights the company’s strategic focus on diversifying its biosimilar range and solidifying its market foothold.

Also, the company announced the acquisition of Switzerland based iQone Healthcare Switzerland in November 2024. This will allow Celltrion to drive direct commercialization of its biosimilars across Europe. In February 2025, Celltrion received EC approval for Eydenzelt (CT-P42), Stoboclo, Osenvelt (CT-P41), and Avtozma® (CT-P47).

Short-term Plans and Future Outlook:

Steqeyma (Ustekinumab) launch planned in the US in February 2025.
Eydenzelt (aflibercept) launch in Europe post its EC approval in February 2025.
Stoboclo and Osenvelt (denosumab) launch in Europe post its EC approval in February 2025.
Avtozma (tocilizumab) launch in Europe post its EC approval in February 2025.

Further details on recent initiatives taken by Celltrion and other biosimilar companies have been provided in detail in the report.

What About Other Biosimilar Companies Around the World?

The above presentation features top four biosimilar developers from a pool of more than 170 players that we have compiled developing more than 900 biosimilar therapies. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

Sources

Top 4 Leading Biosimilar Companies to Watch in 2025

Table of Contents

Discover Below the Details on Top Four Biosimilar Companies

Amgen Invested More than USD 2 billion Across a Portfolio of More Than 10 Biosimilars (either approved or currently under development)

Pfizer With a Portfolio of 8 Approved Biosimilars, is Facing Declining Revenues from Oncology Biosimilars Driven by Lower Net Price in the US

Sandoz Has a Deep Biosimilar Pipeline With 28 Products Under Development; Expanding Production Capacity to Meet the Demand

With a Target to Commercialize 22 Biosimilars by 2030 and a Plan for European Expansion, Celltrion is Entering into Partnerships and Collaborations

What About Other Biosimilar Companies Around the World?

**Amgen Invested More than USD 2 billion Across a Portfolio of More Than 10 Biosimilars (either approved or currently under development)**