No, a biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic. A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological and which has no clinically meaningful differences between the biological product and the original branded product in terms of safety, purity, and potency of the product. The FDA approval process for biologics and biosimilars is somewhat different.
Biosimilars are similar, but not exact copies of the active ingredients, as with generics for small-molecule drugs. Under regulations enacted by the FDA, a biological product may be considered “biosimilar” if data show that the product is “highly similar” to an already-approved biological product. However, as with generics, cost savings for the healthcare system and the consumer will occur with biosimilars; however, these products can be very expensive.
List of FDA-approved biosimilars include:
- Zarxio (filgrastim-sndz) – biosimilar to Neupogen
- Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), Ixifi (infliximab-qbtx) – biosimilar to Remicade
- Erelzi (etanercept-szzs) – biosimilar to Enbrel
- Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm) – both biosimilars to Humira
- Mvasi (bevacizumab-awwb) – biosimilar to Avastin
- Retacrit (epoetin alfa-epbx) – biosimilar to Epogen/Procrit
- Ogivri (trastuzumab-dkst) – biosimilar to Herceptin.