Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, monoclonal antibodies and vaccines. They are used to prevent or treat a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis and autoimmune disorders.
A biosimilar is a biologic medicine that is highly similar to and has no clinically meaningful differences in safety, purity and potency from an already U.S. Food and Drug Administration (FDA) licensed biologic medicine (known as a reference product). Biosimilars can be FDA-approved for all or a subset of the indications of their reference products.
As of May 2021, there are 19 biosimilar FDA-approved products currently available to patients in the U.S., competing against seven reference biologics, with nine additional FDA-approved biosimilars due to come to market over the next several years. With three of the most recent biosimilar launches set to reach nearly 60% shares of volume by the end of their second year on the market, uptake of the coming wave of biosimilars will likely occur much more quickly than occurred for prior biosimilars.
Let’s take a closer look at the unique U.S. marketplace and how patients are benefiting from biosimilars:
- Regulatory Certainty
Since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have been viewed as an important way to bolster competition and increase options for patients. The BPCIA created an abbreviated approval pathway for biosimilars while maintaining 12 years of data protection for innovative biologics, an important incentive for innovative biologic manufacturers.
While the U.S. has not had a biosimilar market in place as long as the European Union (EU), the U.S. market has significantly evolved over the last decade and is rapidly gaining ground. In fact, the U.S. has approved more biosimilar products than the EU had in a comparable period of time. This is largely due to the regulatory predictability and efficiencies that have been provided by the FDA’s successful implementation of the abbreviated approval pathway for biosimilars and the resources provided through the Biosimilar User Fee Act (BsUFA).
- Increasing Pipeline and Competition
In addition to products for oncology, immunology and multiple sclerosis, 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. As of September 2020, there were one-hundred and eight additional biosimilars in development across 22 different molecules. And thanks to increases in education, awareness and experience among health care providers, these additional potential biosimilars are likely to reach patients faster than ever before with incredible potential to reduce health care costs.
- Cost Savings for Patients
In addition to promoting competition and expanding patient choice, biosimilars are also increasingly leading to cost savings in the U.S. Many innovative medicines now compete with multiple biosimilars, with one biologic medicine currently facing competition from five biosimilars. The absolute savings from biosimilars vary, with larger savings realized from more recent launches competing against more costly reference biologics. 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. Savings from biosimilars are modeled to exceed $100 billion over the next five years, a nearly five-fold increase relative to the past five years.
Policymakers can take additional steps to continue fostering a competitive market for biosimilar and innovative biologics, and promisingly, many are already taking action. Most recently in April 2021, the Advancing Education on Biosimilars Act was signed into law, encouraging FDA to maintain and operate an educational website and advance awareness among health care providers, patients and caregivers about biosimilar and interchangeable biosimilar biological products.
To learn more about biologics and biosimilar research and development, visit https://www.phrma.org/en/Advocacy/Research-Development/Biologics-Biosimilars.