Preparing for the Biosimilar Landscape
June 25, 2024To date, there have been 57 biosimilar approvals and 38 launches in the U.S. market, which is good news for your business and team. As new biosimilars enter the market, increased competition brings down the price of the biosimilar and reference product.
As biosimilars continue to grow in use, it is important to understand what they are and their impact in the market.
What are biosimilars?
To understand what a biosimilar is, we need to first talk about biologics.
Biologics are powerful therapies derived from living organisms, such as blood, cells, tissues, or proteins—different from traditional medicines, which are created using chemical processes. Biosimilars are biologic drugs that are “highly similar” and “clinically equivalent” to another biologic “reference” product already approved by the U.S. Food and Drug Administration (FDA).
- Highly similar means that the core characteristics are the same, there might just be minor differences that the FDA controls and monitors.
- Clinically equivalent means that they must have no clinically meaningful differences from their original biologic.
Similar to the relationship between generics and brand-name drugs, biosimilars are safe and clinically effective treatment options that can be used to treat the same condition as the reference biologic.
| Generic | Biosimilar |
| A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. | Biosimilars mimic the active ingredient in the biologic drug it is trying to replicate which means they are highly similar but not identical to the original biologic products. |
What kind of conditions do biosimilars treat?
Biosimilars and their reference biologics are used to treat a wide range of conditions including:
- inflammatory conditions
- diabetes
- kidney conditions
- macular degeneration
- neurological conditions
- some cancers
- more
Why are biosimilars so important?
Biosimilars are supporting affordable prescriptions by aiming to bring the cost down of biologics. Biologics make up for more than $250 billion of the $500 billion prescription market spend. Biosimilars are often priced lower than the reference biologic drug anywhere from 15%-85%*. Competition from biosimilars can lead to price reductions for the reference drug , which is beneficial for patients who continue use of the reference drug. According to the IQVIA Institute for Human Data Science, biosimilars are estimated to bring costs down in the U.S. by $100 billion over the next 5 years.
How are biosimilars developed?
Biosimilars go through a rigorous process, sometimes taking up to a decade to complete. To get these drugs into the market they must go through a three-stage process:
- Characterization and Perfecting the Process– Reference biologics will be scientifically studied for understanding by examining their structure and function. Next, the manufacturer will begin developing and refining the technique to produce a highly similar therapy. The manufacturer will also conduct clinical trials designed to prove both efficacy and safety.
- Confirmation of Biosimilarity– The Food and Drug Administratiomn (FDA) will review all findings in this stage that will be required to confirm biosimilarity for approval.
- Approval — For a biosimilar gain approval from the FDA, it must have no clinically meaningful difference from the biologic reference product, and provide the same benefit in treating the medical condition or disease.
What happens once a biosimilar is approved?
Once a biosimilar is approved, it can then be produced and distributed. However, to get a biosimilar approved as interchangeable, it must go through stricter FDA reviews. When approved for interchangeability, pharmacists can substitute the drug with a biosimilar without consulting the prescriber, as they would interchange a generic drug for a brand-name drug. State laws vary. In New York state, pharmacists must notify the prescriber after the dispensing occurs.
What is Excellus BlueCross BlueShield (BCBS) doing to support the future of biosimilars?
In our ongoing efforts to ensure access to high quality, affordable health care and reduce costs, Excellus BCBS leads the insurance industry in pursuing biosimilar drugs for our members and have been a national leader in biosimilar adoption since their inception.
Biosimilars are an important way to help spur competition that can lower health care costs and increase access to important therapies.
Excellus BCBS was the first standalone health plan to prefer a biosimilar in 2018 in a major drug category. Avastin®, Herceptin® and Rituxan®, used in oncology, now have biosimilars available. Within two years of these drugs being on the market, we have an adoption rate above 70% and have generated more than $30 million in savings for our Health Plan, members, and our community.
Interested in learning more? Reach out to your accountant rep to discuss how biosimilar optimization works for your group.
Additional Resources
Biosimilar Flyer: Advancing Care With Biosimilars – Excellus for Business
*2024 Health Plan Data
Excellus BlueCross BlueShield is a nonprofit independent licensee of the Blue Cross Blue Shield Association