Biologics (also called biological medications) are a complex class of drugs derived from living organisms, such as plant or animal cells. They’re made by reproducing copies of living cells that have been engineered for specific purposes, such as targeting cancer cells.
A biosimilar is a closely engineered copy of an FDA-approved biologic.
Unlike generic versions of drugs, biosimilars are not identical to the brand-name biologic they are duplicating. This is because it’s impossible to duplicate a drug made from a living organism. Slight variations exist within all biologics, including between different batches of the same biologic.
Although biosimilars aren’t exact duplicates of biologics, they must follow strict FDA guidelines to ensure that they are as safe and effective as the brand-name biologic (reference drug) they are copying.
Biosimilars may be available at a lower cost than their biologic counterpart.
Doctors use biologics and biosimilars to treat a variety of conditions,
- cancers, such as breast, lung, and colon
- arthritis, such as rheumatoid and psoriatic
- chronic skin conditions, such as psoriasis
- diabetes
- autoimmune disorders, such as multiple sclerosis
- inflammatory bowel disorders, such as Crohn’s disease, ulcerative colitis
- chronic kidney conditions
- macular degeneration
- osteoporosis
A number of the biologics that have been used to treat cancer now have biosimilar versions that have also been approved by the FDA.
| Biologic reference drug | Biosimilar |
| bevacizumab (Avastin) | Mvasi Zirabev Alymsys Vegzelma Avzivi Jobevne |
| rituximab (Rituxan) | Truxima Ruxience Riabni |
| trastuzumab (Herceptin) | Ogivri Herzuma Ontruzant Trazimera Kanjinti Hercess |
| filgrastim (Neupogen | Zarxio Nivestym Releuko Nypozi |
| pegfilgrastim (Neulasta) | Fulphila Udenyca Ziextenzo Nyvepria Fylnetra Stimufend |
| epoetin alfa (Epogen or Procrit) | Retacrit |
| denosumab (Xgeva) | Wyost Xbryk Osenvelt Bomyntra |
As with all important medical decisions, have a detailed conversation with your doctor about all your treatment options.
If biologics or biosimilars are recommended as part of your treatment, your doctor can provide more information about the medication, including how it works and potential side effects.
Your doctor can also help you determine what recommended medications your insurance plan will or will not cover.