What You Should Know About Biosimilars

As more biosimilar medicines become available, it is important to understand what they are and how they can have a positive impact on our health care system.

What are they?
Biosimilars are biologic medicines that have been developed to be highly similar to an already FDA-approved biologic, or reference biologic. Biologic medicines are large complex molecules produced from living organisms, such as plant cells or animal cells.

Get familiar with biosimilars

Biologics are complex in structure and generally expensive to manufacture.


Biosimilars undergo testing to demonstrate there are no clinically meaningful differences in safety and effectiveness compared to the reference biologic.

Biosimilar manufacturers submit this data to regulatory authorities, like the FDA in the United States. Each local regulatory authority then factors in all the provided data as a “totality of evidence” during the biosimilar approval process.

Did you know?

Over 90% of physicians surveyed in 2021* said they believed that biosimilars have similar effectiveness and safety to the reference brand, and they have a high level of confidence in the FDA-approval process for biosimilars.

What Is a Biosimilar?
*A 2021 online Organon unpublished omnibus survey of US physicians (n=500) who were geographically dispersed and evenly comprised of Rheumatologists, Oncologists, Immunologists, Gastroenterologists, and Family Practice/General Practitioners.

Why were biosimilars developed?

Biosimilars present an opportunity to significantly reduce spending within the health care system by creating competition in the market and increasing access to these medicines. Click through to see more.

Where we are now and where we're going

The United States now has more than 20 biosimilars available, and by 2025, biosimilars are expected to generate more than $133 billion in cost savings to the health care system. These savings can potentially make room for innovation and improve access to more treatment options.

Learn about the biosimilar impact

In the 10 years since the passage of the BPCIA, $20 billion worth of health care savings have been associated with available biosimilars in the United States.

At a time when half of the world’s population lacks access to essential health services and global health spending outpaces economic growth, the promise of biosimilars cannot be ignored.

With an increased focus on biosimilars and deep biologics expertise, Organon aims to improve health care system and treatment access by providing high-quality biosimilar medicines to health care systems, providers, and patients.

With the country's high health care spending, the promise of biosimilars cannot be ignored.

Other Resources

Get Familiar with Biosimilars

One-minute video introducing biosimilars, their purpose, and potential impact.

Get Familiar with Biosimilars

Why Biosimilars Matter Video

One-minute video for anyone interested in why biosimilars matter.

Why Biosimilars Matter Video

Rigorous Approval Video

One-minute video for health care professionals that covers the rigorous biosimilar approval process.

The Rigorous Biosimilar Approval Process