Biosimilars Explained
What biosimilars are, how FDA approves them, and which ones are available in 2026
Key Takeaways
- A biosimilar is not a generic — it is a highly similar but not identical copy of a biologic
- The FDA approves biosimilars after rigorous comparative testing
- Biosimilars are interchangeable in most cases — your doctor or pharmacist can switch
- Biosimilars may have different savings programs than the reference biologic
- BiologicHealthPlus can advise you on the best option for your insurance
What Is a Biosimilar?
A biosimilar is a biological product that has been demonstrated to be highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, and potency. The FDA approves biosimilars through a rigorous pathway that requires extensive analytical, preclinical, and clinical data showing similarity to the reference product.
Unlike generic drugs (which are chemically identical to their brand-name counterparts), biologics and biosimilars are complex proteins that cannot be exactly copied. Minor structural variations between a biosimilar and its reference product are expected and do not affect clinical performance.
Interchangeable Biosimilars
The FDA designates some biosimilars as interchangeable, meaning they may be substituted for the reference biologic at the pharmacy level without requiring prescriber intervention — similar to how generic drugs work for small-molecule medications. Not all biosimilars receive this designation.
Available Biosimilars in 2026
| Reference Biologic | Approved Biosimilars | Condition(s) |
|---|---|---|
| Humira (Adalimumab) | Hadlima, Hyrimoz, Cyltezo, Abrilada, Yusimry, Idacio, Hulio | RA, Crohn's, UC, Psoriasis, PsA, AS, HS |
| Remicade (Infliximab) | Inflectra, Renflexis, Avsola, Ixifi, Zymfentra | RA, Crohn's, UC, PsA, AS, Psoriasis |
| Stelara (Ustekinumab) | Wezlana, Selarsdi, Otulfi, Imuldosa | Psoriasis, PsA, Crohn's, UC |
| Enbrel (Etanercept) | Eticovo, Erelzi | RA, Psoriasis, PsA, AS |
| Actemra (Tocilizumab) | Tyenne | RA, Giant Cell Arteritis |
Ask BiologicHealthPlus About Biosimilar Options
Our pharmacists can compare the biologic and its biosimilars based on your insurance plan and help you choose the most cost-effective option. Contact us at no charge.
Talk to a Pharmacist →📚 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.