Research & Development

Biologics & Biosimilars

What are Biologics and Biosimilars?

Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines. Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.

A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA).

Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure.

In 2010, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars while maintaining 12 years of data protection to incentivize the development of new innovative biologics. This framework has provided more options for patients, increased access to lifesaving medications, and lowered health care costs through additional competition in the marketplace.

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FDA's Role in Ensuring Access to Safe and Effective Options for Patients

To date, the FDA has issued numerous draft and final guidance documents to provide clarity to biosimilar manufacturers regarding the data needed to support applications to FDA for biosimilar and interchangeable biologic products. The FDA approved the first biosimilar product for marketing in the United States in March 2015. Recognizing biosimilars’ important role, in 2018 the FDA introduced the Biosimilars Action Plan to help spur additional competition. This plan focuses on four areas of FDA activities: 1) improving the efficiency of the biosimilar and interchangeable product development and approval process; 2) maximizing scientific and regulatory clarity for the biosimilar product development community; 3) developing effective communication to improve understanding of biosimilars among patients, clinicians, and payors; and 4) supporting market competition.1




Increasing Competition For Biologics and Biosimilars

The U.S. biologics and biosimilars market is evolving rapidly, and the benefits for patient access and controlling health care costs will continue to grow over time as more medicines are introduced. As of June 2020, there are 17 biosimilars on the market in the U.S. competing against 7 reference biologics, with 9 additional FDA approved biosimilars due to come to market over the next several years. As of March 2020, there were 79 programs enrolled in the Biosimilar Product Development (BPD) Program. The rich pipeline of potential biosimilar and interchangeable products currently in development as well as current market experience indicates that there is still significant potential for cost savings in the United States market.

Recent studies project that biosimilars could significantly reduce spending in the U.S. health care system. Mulcahy et al. have projected that the use of biosimilars will reduce spending on biologic drugs by $54 billion from 2017 to 2026,3  and the IQVIA Institute estimates the U.S. health care system will save $160 billion due to biosimilar competition over the next 5 years.4

Biosimilars are already realizing their promise, leading to lower prices and savings for patients. A recent analysis of the market dynamics of four biologics and their biosimilars demonstrated that the net prices of all the originator biologics decreased following the entry of biosimilars. In the Medicaid program, discounts increased by between 20.1 and 35.2 percentage points.5

As the market experience with biosimilars increases, we expect product usage to play in expanded role in options for patients and further decrease prescription drug spending. Experts have argued that the coming wave of biosimilars will penetrate the market even more quickly than those already available for patients.6

3. Mulcahy, A. W., Hlavka, J. P., and Case, S. R. (2017). Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Retrieved from:
4. IQVIA Institute for Human Data Science. (April 2018). Medicine use and spending in the U.S.: a review of 2017 and outlook to 2022. Retrieved from:
5. San-Juan-Rodriguez A, Gellad WF, Good CB, Hernandez I. (2019) Trends in List Prices, Net Prices, and Discounts for Originator Biologics Facing Biosimilar Competition. JAMA Netw Open. 2(12):e1917379. Available at: doi:10.1001/jamanetworkopen.2019.1737
6. Fein, Adam. (2019) We Shouldn’t Give Up on Biosimilars – And Here Are the Data to Prove IT. Drug Channels. Available at:


Supporting a Robust Biosimilars Market in the U.S.

To foster a robust biosimilar market, we believe the following steps should be taken:

  • Ensure the long-term stability of the Biosimilar User Fee Act (BsUFA) program through financial transparency, efficiency, and accountability
  • Increase focus on provider and patient education including the development and dissemination of evidence-based materials on the full range of treatment options, including biosimilars.
  • Address barriers to appropriately structured alternative payment models, particularly in Medicare, that have the ability to increase competition among innovator and biosimilar products.
  • Advance meaningful rebate reform that would remove barriers to biosimilar uptake and promote access and competition.
  • Increase transparency for patents on biologic products consistent with what is currently available in the FDA Orange Book for drug products. Policies that relate to listing patents for biologics should encourage competition without creating an undue burden or risk, requiring overbroad listings that could mislead the public, or improperly disclosing protected trade secrets.