News/Blogs
FDA’s Proposed Biosimilar Guidelines Could Open Door to Greater Savings
The FDA’s recently released draft guidance could make it easier and faster for biosimilar medications to reach the market – and our clients are already ahead of the curve.
What the FDA is Proposing
On October 29, the FDA announced significant reforms to streamline biosimilar development.1,2 The proposed changes would reduce the requirement for costly, time-consuming comparative efficacy studies that often add little scientific value, instead allowing manufacturers to rely more on analytical testing. If finalized, this could cut development time in half and reduce costs by up to $100 million per biosimilar.2
Why does this matter? Because biologics represent just 5% of prescriptions but account for 51% of total drug spending.1,2 Despite FDA approval of 76 biosimilars, market adoption has remained stubbornly low—under 20%.1 These proposed guidelines aim to increase the availability of affordable alternatives to expensive biologics treating cancer, autoimmune diseases, and other serious conditions.
In a related development, the FDA issued separate guidance in December about promotional labeling and advertising for biosimilars. This guidance clarifies that promotional materials cannot suggest that a biosimilar is less safe or effective than a reference product solely because it lacks an “interchangeable” designation. By reducing market confusion around biosimilar messaging, this finalized guidance complements the streamlining efforts and could further encourage biosimilar adoption.
What This Could Mean Moving Forward
The FDA’s proposed reforms address the most significant barriers that have kept biosimilars from reaching patients: development costs, lengthy approval timelines, confusion about interchangeability, and messaging that drives adoption. The hope is that these actions will foster further biosimilar development, acceptance, and uptake, and lower costs.
The Real-World Impact for Your Clients
More biosimilars entering the market faster means more opportunities for clients to reduce costs without compromising care. And that’s where our Biosimilar Advantage Formulary comes in.
We’ve been actively driving biosimilar adoption for our shared clients, achieving results that demonstrate exactly why this FDA guidance matters, including:
- 90% biosimilar conversion rate in recent months
- $1,100 in savings per prescription for autoimmune therapies
- Specific conversions achieving substantial savings, such as Humira biosimilars (up to $6,072 per prescription), and Stelara to Wezlana ($23,500 per prescription),
- Nimble adaptation to a rapidly evolving market, with low cost biosimilars added to the formulary as soon as available.
Our Biosimilar Advantage Formulary wasn’t designed to wait for regulatory changes – it was built to capture upfront savings opportunities as they emerge.
Questions about how these FDA changes impact your clients’ pharmacy benefit strategies? Reach out to your account team or email Sales@ServeYouRx.com. We’re here to help you navigate these opportunities and maximize value for the groups you serve.
Sources:
- U.S. Food and Drug Administration. “FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs.” October 29, 2025.
- McPhillips, Deidre. “FDA to streamline approvals for generic biological drugs in latest move targeting health costs.” CNN. October 29, 2025.
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