TABLE 1
FDA-approved biosimilars in oncology 2
Reference product Approval date Biosimilar drug name Manufacturer
Bevacizumab ( Avastin ) |
September 2017 |
Mvasi |
|
|
( bevacizumab-awwb ) |
June 2019
April 2022
September 2022
Cost and reimbursement are also important variables to assess if the same formulary is used for the inpatient hospital and ambulatory clinics or satellite facilities . When a product is first approved , there is a lag time to availability for purchase . Biosimilar manufacturers may not be prepared for rapid uptake of their product , which may result in supply chain issues . There are several items that must be considered by a hospital P & T committee before adding a biosimilar product to formulary and these are discussed in detail later in this handbook .
Zirabev ( bevacizumab-bvzr )
Alymsys ( bevacizumab-maly )
Vegzelma ( bevacizumab-adcd )
Epoetin-alfa ( Epogen ) |
May 2018 |
Retacrit |
|
|
( epoetin alfa-epbx ) |
Filgrastim ( Neupogen ) |
March 2015 |
Zarxio |
|
|
( filgrastim-sndz ) |
July 2018
February 2022
Nivestym ( filgrastim-aafi )
Releuko ( filgrastim-ayow )
Pegfilgrastim ( Neulasta ) |
June 2018 |
Fulphila |
|
|
( pegfilgrastim-jmdb ) |
November 2018
November 2019
June 2020
May 2022
September 2022
Udenyca ( pegfilgrastim-cbqv )
Ziextenzo ( pegfilgrastim-bmez )
Nyvepria ( pegfilgrastim-apfg )
Fylnetra ( pegfilgrastim-pbbk )
Stimufend ( pegfilgrastim-fpgk )
Rituximab ( Rituxan ) |
November 2018 |
Truxima |
|
|
( rituximab-abbs ) |
Trastuzumab ( Herceptin )
July 2019
December 2020
December 2017
December 2018
January 2019
March 2019
June 2019
Ruxience ( rituximab-pvvr )
Riabni ( rituximab-arrx )
Ogivri ( trastuzumab-dkst )
Herzuma ( trastuzumab-pkrb )
Ontruzant ( trastuzumab-dttb )
Trazimera ( trastuzumab-qyyp )
Kanjinti ( trastuzumab-anns )
Amgen
Pfizer
Amneal Pharmaceuticals
Celltrion
Hospira
Sandoz
Hospira
Amneal Pharmaceuticals
Mylan GmbH
Coherus
Sandoz
Pfizer
Amneal Pharmaceuticals / Kashiv Biosciences
Fresenius Kabi
Celltrion
Pfizer
Amgen
Mylan GmbH
Celltrion
Samsung Bioepis
Pfizer
Amgen
Conclusions In the US , several barriers exist to implementation of biosimilars . Some may be remedied by education of providers and patients , while others are more difficult to overcome such as the regulatory hurdles and reimbursement issues . Many biosimilars are in the pipeline with the goal of further diversifying the biologic and biosimilar landscape . The US continues to learn how best to incorporate biosimilars into the health care system .
References 1 Mulcahy AW , Hlavka JP , Case SR . Biosimilar cost savings in the United States . RAND Health Quarterly 2018 ; 7 ( 4 ): 3 . 2 US Food and Drug Administration . Biosimilar Product Information . www . fda . gov / drugs / biosimilars / biosimilarproduct-information ( accessed October 2022 ). 3 Rader RA . Biosimilars / Biobetters Pipeline Directory , online database . https :// www . biosimilardevelopment . com / doc / biosimilars-pipelineshows-remarkable-sustainedgrowth-0001 ( accessed October 2022 ). 4 Leonard E et al . Factors affecting health care provider knowledge and acceptance of biosimilar medicines : a systematic review . J Manag Care Spec Pharm 2019 ; 25 ( 1 ): 102 – 12 . 5 Barsell A , Rengifo-Pardo M , Erlich A . A survey assessment of U . S . dermatologists ’ perceptions of biosimilars . J Drugs Dermatol 2017 ; 16 ( 6 ): 612 – 15 . 6 Cohen H et al . Awareness , knowledge , and perceptions of biosimilars among specialty physicians . Adv Ther 2017 ; 33 ( 12 ): 2160 – 72 . 7 Gibofsky A , Badawi S . Biosimilar knowledge among U . S . rheumatologists – a survey [ abstract ]. Arthritis Rheumatol 2017 ; 69 ( Suppl 10 ). https :// acrabstracts . org / abstract / biosimilar-knowledge-amongus-rheumatologists-a-survey / ( accessed October 2022 ). 8 Trotta F et al . Impact of guidance on the prescription patterns of G-CSFs for the prevention of febrile neutropenia following anticancer chemotherapy : a populationbased utilization study in the Lazio region . BioDrugs 2017 ; 21 ( 2 ): 117 – 24 . 9 Nabhan C , Valley A , Feinberg BA . Barriers to oncology biosimilars uptake in the United States . Oncologist 2018 ; 23 ( 11 ): 1261 – 5 . 10 Pineles D et al . Patient perceptions regarding the use of biosimilars in inflammatory bowel disease . Am J Gastroenterol 2017 ; 112 : S418 – S419 . 11 Harvey RD et al . How will the cost of biosimilars affect patients ’ willingness to receive them ? J Clin Oncol 2019 ; 37:15-suppl , e18338-e18338 . 12 Heled Y . The case for disclosure of biologics manufacturing information . J Law Med Ethics 2019 ; 47 ( 4 _ suppl ): 54 – 78 . 13 US 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 ). Guidance for industry reference product exclusivity for biological products filed under section 351 ( a ) of the PHS Act . www . fda . gov / media / 89049 / download ( accessed October 2022 ). 14 Dolan C . Opportunities and challenges in biosimilar uptake in oncology . Am J Manag Care 2018 ; 24 ( 11 Suppl ): S237 – S243 .
14 | 2023 | hospitalpharmacyeurope . com