To understand what a biosimilar drug is, you first must understand biologics. Biologic drugs are advanced therapies used for treatment of various conditions including Crohn's disease, Rheumatoid Arthritis, Oncology and Multiple Sclerosis. Biologic medications contain substances that have been created by using living sources like plant or animal cells. Biologics are also hard to copy, which is why you’ll never see a “generic” version of a biologic drug. Instead, what you’ll find are biosimilars.
Biosimilars are similar to the original biologic, or “reference,” drug, but not identical. They can, however, accomplish many of the same things generic drugs do by encouraging competition — which may drive down prices for consumers — and increasing treatment options for plan members and their health care providers.
And while biosimilars are not identical to the reference drugs on which they’re based, they have no clinically meaningful differences in their safety and effectiveness. Like their reference products, biosimilars:
- Meet the FDA’s rigorous standards for approval
- Are manufactured in FDA-licensed facilities
- Are tracked as part of post-market surveillance to ensure continued safety1
Additionally, an “interchangeable” biosimilar product is a biosimilar that meets additional requirements that make the drug suitable to be substituted without consulting the health care provider who prescribed the reference product. This is much like the way generic drugs are routinely substituted for brand-name drugs.2
What role, then, should biosimilars play in your prescription benefit offering? At CarelonRx, we assess the opportunities in the market, considering the best possible management and cost strategies available for our clients.
We know the lowest overall cost strategy does not always mean the lowest cost drug based on market price. Therefore, we approach biosimilars with the same rigor as the rest of our pharmaceutical approaches — ensuring our strategic direction aligns with external factors and drives the best outcomes, always focusing on clinical efficacy first and balancing with cost-effectiveness. We will continue to position the best possible drugs that deliver the best health outcomes, measured by lower hospitalizations, lower emergency visits, fewer inpatient/outpatient admissions, fewer side effects, reduced adverse events, etc.
In evaluating available biosimilars, we balance several considerations, including federal and state regulations on interchangeability, specific biosimilar drug attributes, pricing, manufacturer rebates, and the ability for the biosimilar manufacturers to supply the marketplace. In this way, biosimilar utilization fits perfectly into our approach of managing and improving total member health.
This process reflects CarelonRx’s firm commitment to providing optimal clinical and cost options for plan members, while supporting the fiscal responsibilities of the plan sponsors who provide them with their prescription benefits.
1. AJMC The Center for Biosimilars: Contributor: The US Biosimilar Market Outlook for 2023 (accessed June 2023): centerforbiosimilars.com
2. FDA: Review and Approval (accessed July 2023): fda.gov