What are Biosimilar Medications?

A biosimilar a biologic drug that is ‘similar’ to another biologic drug (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA), but they are not considered generic medications. Biologic medications are large, complex molecules or mixtures of molecules that may be composed of living material and virtually impossible to replicate identically. Biosimilars are highly similar to the reference product in terms of safety and purity and potency, but they may have minor differences in clinically inactive components.1

How are Biosimilars Approved:

All FDA-approved medications, including biological products, undergo a rigorous evaluation so that patients are assured of the medication’s safety, efficacy and quality.2 Similar to generic products, the role of biosimilars is to provide patients with a less expensive therapy options. Generic medications are bioequivalent to brand name medications, and are non-complex molecules whereas biosimilars are complex molecules that may be produced in a living organism.

Prescribing Biosimilars:

Biosimilars can be prescribed in the same manner as reference products; however, they may not always be substitutable. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) states that an interchangeable product may be substituted for the reference product without the authorization from the provider who prescribed the reference product. However, for biosimilar products that are not classified as interchangeable, substitution at the pharmacy is not allowed without contacting the provider for approval.

Currently approved biosimilar agents include:

Drug Name Approval Date Product
Hadlima (adalimumab-bwwd) July 2019 Humira
Ruxience (rituximab-pvvr) July 2019 Rituxan
Zirabev (bevacizumab-bvzr) June 2019 Avastin
Kanjinti (trastuzumab-anns) June 2019 Herceptin
Eticovo (etanercept-ykro) April 2019 Enbrel
Trazimera (trastuzumab-qyyp) March 2019 Herceptin
Ontruzant (trastuzumab-dttb) January 2019 Herceptin
Herzuma (trastuzumab-pkrb) December 2018 Herceptin
Truxima (rituximab-abbs) November 2018 Rituxan
Udenyca (pegfilgrastim-cbqv) November 2018 Neulasta
Hyrimoz (adalimumab-adaz) October 2018 Humira
Nivestym (filgrastim-aafi) July 2018 Neupogen
Fulphila (pegfilgrastim-jmdb) June 2018 Neulasta
Retacrit (epoetin alfa-epbx) May 2018 Procrit, Epogen
Ixifi (infliximab-qbtx) December 2017 Remicade
Ogivri (trastuzumab-dkst) December 2017 Herceptin
Mvasi (bevacizumab-awwb) September 2017 Avastin
Cyltezo (adalimumab-adbm) August 2017 Humira
Renflexis (infliximab-abda) May 2019 Remicade
Amjevita (adalimumab-atto) September 2016 Humira
Erelzi (etanercept-szzs) August 2016 Enbrel
Inflectra (infliximab-dyyb) April 2016 Remicade
Zarxio (filgrastim-sndz) March 2015 Neupogen

1. FDA Biological Product Definitions. Available at: https://www.fda.gov/media/108557/download. Accessed August 15, 2019.
2. Biosimilar Development, Review, and Approval. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval. Accessed August 15, 2019.