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.
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.
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- The Paradigm Shift
- WellDyneRx Named a Best Place to Work by CareerSource
- ACA Changes to Preventive Care Coverage Requirements
- IRS High Deductible Health Plan (HDHP) Rules
- Flu Vaccinations and Recommendations
- What are Biosimilar Medications?
- H2 2019 Drug Pipeline Reports
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- Healthcare Observances September
- FDA Approved List