The FDA’s approval of biosimilars is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates that the biosimilar product is equivalent in efficacy and safety to the branded medication.
Biosimilars are the best approximation of a “generic” for a biologic- they are highly similar to their reference product and demonstrate no clinically meaningful differences in safety, purity and potency. Biosimilars undergo a very rigorous approval process which leaves little room for residual uncertainty in its similarity to the reference biologic. In fact, the development process of a biosimilar is more stringent than that of a generic small molecule drug.
The American Society of Clinical Oncology (ASCO), Centers for Medicare and Medicaid Services (CMS) and Medicare Payment Advisory Commission (MedPAC) have each incorporated biosimilars in treatment guidelines, formulary design guidance, and reimbursement methodologies, respectively, to encourage biosimilar uptake by clinicians.
Biosimilars have been widely used across the European Union and other nations for over a decade and have demonstrated comparable efficacy and safety as reference biologics. Because of increased competition and decreased costs of marketing, biosimilars usually provide significant cost savings. Since patients usually pay a percentage of the costs of a drug, these cost savings usually translate to decrease costs for Healthcare Partners Nevada patients.
Biosimilar medications listed below (and any newer biosimilars listed on the U.S. Food and Drug Administration website) are considered preferred. All other medications in a treatment category are considered non-preferred. The most up-to-date listing of all approved biosimilar medications can be accessed online for free at: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
There should be a failure of an adequate 6-month trial of the preferred (biosimilar) medication or a contraindication to that medication before a non-preferred branded (non-biosimilar) medication can be prescribed.
Step Therapy Part B Medications
The following list of biosimilar drugs are all considered preferred and that you must try and not do well on the biosimilar before you can use the branded drug.
|Biosimilar Name||Reference Product||Approval Date|
|Abrilada (adalimumab-afzb)||Humira (adalimumab)||November-19|
|Amjevita (Adalimumab -atto)||Humira (adalimumab)||September-16|
|Avsola (infliximab-axxq)||Remicade (infliximab)||December-19|
|Cyltezo (Adalimumab-adbm)||Humira (adalimumab)||August-17|
|Erelzi (Etanercept-szzs)||Enbrel (etanercept)||August-16|
|Eticovo (etanercept-ykro)||Enbrel (etanercept)||April-19|
|Fulphila (pegfilgrastim-jmdb)||Neluasta (pegfilgrastim)||June-18|
|Hadlima (adalimumab-bwwd)||Humira (adalimumab)||July-19|
|Herzuma (trastuzumab-pkrb)||Herceptin (trastuzumab)||December-18|
|Hyrimoz (adalimumab-adaz)||Humira (adalimumab)||October-18|
|Inflectra (Infliximab-dyyb)||Remicade (infliximab)||April-16|
|Ixifi (infliximab-qbtx)||Remicade (infliximab)||December-17|
|Kanjinti (trastuzumab-anns)||Herceptin (trastuzumab)||June-19|
|Mvasi (Bevacizumab-awwb)||Avastin (bevacizumab)||September-17|
|Nivestym (filgrastim-aafi)||Neupogen (filgrastim)||July-18|
|Ogivri (trastuzumab-dkst)||Herceptin (trastuzumab)||December-17|
|Ontruzant (trastuzumab-dttb)||Herceptin (trastuzumab)||January-19|
|Renflexis (Infliximab-abda)||Remicade (infliximab)||May-17|
|Retacrit (epoetin alfa-epbx)||Epogen (epoetin-alfa)||May-18|
|Ruxience (rituximab-pvvr)||Rituxan (rituximab)||July-19|
|Trazimera (trastuzumab-qyyp)||Herceptin (trastuzumab)||March-19|
|Truxima (rituximab-abbs)||Rituxan (rituximab)||November-18|
|Udenyca (pegfilgrastim-cbqv)||Neulasta (pegfilgrastim)||November-18|
|Zarxio (Filgrastim-sndz)||Neupogen (filgrastim)||March-15|
|Ziextenzo (pegfilgrastim-bmez)||Neluasta (pegfilgrastim)||November-19|
|Zirabev (bevacizumab-bvzr)||Avastin (bevacizumab)||June-19|
Have questions about your coverage?
We understand that medication coverage can be confusing at times. Below are resources to help you.
- Contact Dr. Steven Evans, Senior Medical Director of Utilization and Quality Management
- Phone: 702-990-8134
- Email: email@example.com
- Visit the U.S. Food & Drug Administration biosimilar online resources:
- U.S. Food and Drug Administration. FDA news release. FDA approves first biosimilar product Zarxio. March 6, 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm (Accessed April 13, 2017).
- U.S. Food and Drug Administration. Information for Healthcare Professionals (biosimilars). Last updated January 12, 2017. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm (Accessed April 13, 2017).
- Health Aff (Millwood). 10 October 2013. Available at: http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=100 (Accessed June 20, 2016).
- U.S. Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Guidance for Industry. April 2015. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241720.htm (Accessed April 13, 2017)
- National Conference of State Legislatures. State laws and legislation related to biologic medications and substitution of biosimilars. Last updated March 31, 2017. Available at: http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx (Accessed April 13, 2017)
- Christl L. Overview of the Regulatory Pathway and FDA’s Guidance for the Development and Approval of Biosimilar Products in the US. U.S. Food and Drug Administration Center for Drug Evaluation and Research. February 9, 2016. Available at: https://google2.fda.gov/search?q=biosimilar+extrapolation&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=* (Accessed February 2017)
- Federal Register. Nonproprietary naming of biological products; draft guidance for industry. August 28, 2015. http://www.federalregister.gov/articles/2015/08/28/2015-21383/nonroprietary-naming-of-biological-products-draft-guidance-for-industry-availability (Accessed June 21, 2016)