News & Insights
Check out EpiphanyRx’s latest Fast Five Series post!
Got 5 minutes (or less)?
We’re sharing 5 quick industry insights about pharmacy benefits.
Biosimilars are a hot topic in the pharmacy industry right now. Wondering what all the buzz is about?
In this Fast Five, we asked our clinical experts, Janelle Sheen and Imke Scheepers, to share the basics about biosimilars as well as some key insights on this topic.
Read Time: < 5 minutes
1. What is a biosimilar?
The Food and Drug Administration (FDA) defines a biosimilar as a biological product used in the prevention or treatment of disease and highly similar to an FDA-approved biologic (known as a brand reference product).
Biosimilars are medications with complex manufacturing compared to traditionally developed medications. They are intricately designed molecules that must demonstrate clinical similarity to their brand reference product. Biosimilars increase competition within a therapy class and will often drive down costs over time.
The biosimilar has no clinically meaningful difference from a reference product and is FDA-approved for use after rigorous evaluation and testing is demonstrated by the manufacturer applicant.
2. That sounds complicated! Is there an easier way to describe biosimilars?
The fast five (second) definition: A biologic medication is a product created using living organisms.
It is impossible to have an exact copy, so it is called a biosimilar to the brand reference product.
3. How is a biosimilar different from a generic?
A biosimilar is not a generic. Generic drugs are chemically identical to their reference product. Generic medications have the same active ingredient as brand medications. Biosimilars are made from living organisms and don’t contain identical ingredients. Thus, stringent testing to demonstrate comparability is required.
Biosimilars undergo a different FDA approval pathway than generics, but both have the same efficacy as the reference product.
Some biosimilars require a new prescription from the prescriber and some are interchangeable and do not require a new prescription. Generics, on the other hand, are usually interchangeable and do not require a new prescription.
4. Why are we hearing so much about biosimilars right now?
The first biosimilar to Humira® (adalimumab), Amgen’s Amjevita™, launched on February 1, 2023.
This was a significant event as it is the first of more than ten biosimilar products expected to come to market this year with the potential to drive greater affordability of therapy for many inflammatory conditions.
We anticipate a dynamic landscape in 2023, with additional Humira® biosimilars launching and positively impacting the competitive marketplace.
5. What considerations are important in assessing new biosimilar products?
Some industry players may deploy a specific short-term strategy for biosimilars only focused on rebates. A pharmacy benefit partner who has clients’ and members’ best interests in mind should evaluate each of the following criteria for every biosimilar that hits the market:
- Interchangeability including member and provider impact: Will this new product require a new prescription? Will the member need to change to the new biosimilar now and then change to another one several months later?
- Clinical effectiveness: Will prescribers use this new biosimilar, and does it have the same indications as the brand? Will the biosimilar formulation be dosed and administered the same as the brand?
- Net cost: How does this new biosimilar affect the net cost of this medication and possibly others on the formulary? Net cost is the cost after pharmacy discounts, rebates, and copay assistance.
- Availability: When will the product be available, and is the manufacturer prepared to supply enough product to meet demand?
- Pipeline forecast: Will this be the only biosimilar? How many other biosimilar manufacturers are seeking approval, and what is their anticipated entry to market?
- Programs: Does the new biosimilar have any financial programs to help members, and are they comparable to the brand?
Janelle Sheen, PharmD, Senior Director of Clinical Strategy at EpiphanyRx has over 20 years of industry experience. Her background includes extensive work in utilization management strategies with specialty medications in both commercial and government pharmacy and medical benefits.
Imke Scheepers, PharmD, Clinical Account Executive at EpiphanyRx recently completed her managed care residency. She was able to spend time learning from experts in the industry, including those at ICER and AMCP.