Are Biosimilars Safe?
What the FDA approval process and real-world evidence show about biosimilar safety
Quick Answer
Yes. FDA-approved biosimilars are required to demonstrate no clinically meaningful differences in safety compared to the reference biologic. The FDA's rigorous approval pathway — combined with post-marketing surveillance — has established a strong track record for approved biosimilars. Major medical societies including the ACR, AGA, AAD, and ACG support biosimilar use in appropriate patients.
The FDA Safety Standard for Biosimilars
For a biosimilar to receive FDA approval, the manufacturer must demonstrate that there are no clinically meaningful differences in safety, purity, and potency between the biosimilar and the reference product. This includes:
- Structural and functional characterization showing the molecule behaves identically
- Immunogenicity testing confirming the biosimilar does not provoke more immune reactions
- Comparative clinical pharmacology studies
- At least one comparative clinical trial confirming similar efficacy and safety
- Post-approval pharmacovigilance commitments
What Real-World Evidence Shows
Since the first biologics biosimilars were approved in the US and internationally, extensive real-world evidence has accumulated. Large registry studies, observational data, and switching studies from Europe (where biosimilars have been available since 2006) consistently show:
📊 Equivalent Efficacy
Patients who switch to biosimilars maintain their disease remission at rates comparable to those who continue on the reference biologic.
🛡️ No New Safety Signals
Post-marketing surveillance of approved biosimilars has not identified new or unexpected safety signals compared to reference biologics.
🔬 Similar Immunogenicity
Anti-drug antibody rates in switching studies are generally comparable between biosimilars and reference products.
🌍 European Track Record
Europe approved infliximab biosimilars in 2013 and adalimumab biosimilars in 2018 — millions of patient-years of real-world data support biosimilar safety.
💬 Questions About Biosimilar Safety for Your Situation?
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Talk to a Pharmacist →Related: What is a biosimilar? · Humira biosimilars guide · Biosimilars explained
📚 Sources & Further Reading
Content developed with reference to leading health organizations, peer-reviewed research, and FDA prescribing information.
Medical Disclaimer: Educational content reviewed by the BiologicHealthPlus Clinical Team. Consult your healthcare provider for personalized advice. Last reviewed: August 2026.