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.


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

The Biosimilars User Fee Act (BsUFA) was enacted in 2012 to help provide FDA with resources and staffing specifically to support a biosimilar approval pathway and promote greater consistency, certainty, and predictability in the review of biosimilar and interchangeable biologic products. BsUFA has played an essential role in strengthening the FDA’s ability to implement a regulatory review approach for biosimilar products that is consistent with the Agency’s high standards for scientific rigor and patient safety. BsUFA II (FY2018 – FY2022) was informed by lessons learned from initial experiences with the program and included initiatives to enhance the biosimilar review model, promote more informative engagement between the FDA and biosimilar product developers, and help ensure the long-term sustainability of BsUFA activities.1

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 also 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.2


1.  FDA, “BsUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022,”

2. FDA, “Biosimilars Action Plan: Balancing Innovation and Competition,” (July 2018)


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 November 2020, there are 18 biosimilars on the market in the U.S. competing against 7 reference biologics, with 10 additional FDA approved biosimilars due to come to market over the next several years.2 In FY 2020, there were 104 programs enrolled in the Biosimilar Product Development (BPD) Program.3 In addition to products for oncology, immunology, and multiple sclerosis, since the successful addition of the transition products to the biosimilar pathway in March 2020 it is now possible for manufacturers to develop biosimilars for diseases including diabetes, respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and many more.4 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.

Many innovator medicines now compete with multiple biosimilar versions, with one biologic medicine currently facing competition from 5 biosimilars.5  The absolute savings from biosimilars vary with larger savings realized from more recent launches competing against more costly products. As of July 2020 the difference between the originator and the mean Average Sales Price (ASP) of their biosimilars ranged from 8.1% to 45.1% lower than the originator products (including insulins).6  In the Medicaid program, discounts increased by between 20.1 and 35.2 percentage points.7  Annualized savings from biosimilars reached $6.5B in the second quarter of 2020, and savings are modeled to exceed $100 billion in aggregate over the next five years.8

Biosimilars are also achieving significant market uptake, with the three most recently-launched biosimilars in 2019 achieving between 20% and 42% of market share within their first year.9  These trends suggest that uptake by doctors and patients of the coming wave of biosimilars will occur much more quickly than occurred for biosimilars launched earlier, in part due to increased education, awareness and experience among health care providers and patients.  


2. PhRMA analysis of FDA, Biosimilar Product Information,; IQVIA Institute, “Biosimilars in the United States 2020 – 2024,” (October 2020),

3. U.S. FDA. BsUFA Background and Reauthorization Process. November 19, 2020. Available at:

4. U.S. FDA (2020, March 23). Insulin Gains New Pathway to Increased Competition [Press release]. Retrieved from;

5. Fein, Adam. (2020). The Booming Biosimilar Market of 2020. Drug Channels. Retrieved from

6. IQVIA Institute Report (2020). Biosimilars in the United States 2020 – 2024. Retrieved from

7. 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

8. IQVIA Institute Report (2020). Biosimilars in the United States 2020 – 2024. Retrieved from

9. Ibid.


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.
  • Ensure the successful implementation of meaningful rebate reform that remove barriers to biosimilar uptake and promote access and competition.