References 1 Ledón N , Lage A . Biosimilars and the real world . MEDICC Rev 2017 ; 19 ( 4 ): 6 . 2 Wish J . Understanding the ever-changing world of biosimilars . J Manage Care Med 2019 ; 21 ( 3 ): 24 – 9 . 3 . Sullivan PM , DiGrazia LM . Analytic characterization of biosimilars . Am J Health-System Pharm 2017 ; 74 ( 8 ): 568 – 79 . 4 Cazap E et al . Global acceptance of biosimilars : Importance of regulatory consistency , education , and trust . Oncologist 2018 ; 23:1188 – 98 . 5 Declerck P et al . Monoclonal antibody biosimilars in oncology : Critical appraisal of available data on switching . Clin Ther 2018 ; 40 ( 5 ): 798-809 . e2 6 Mehr S , Brook , R . Factors influencing the economics of biosimilars in the US . J Med Econ 2017 ; 20 ( 12 ): 1268 – 71 . 7 Gellad W , Good CB . Adalimumab and the challenges for biosimilars . JAMA 2019 ; Oct 23 [ Epub ahead of print ]. 8 Nabhan C , Valley A , Feinberg B . Barriers to oncology biosimilars uptake in the United States . Oncologist 2018 ; 23:1261 – 5 9 The Biosimilars Council ; A Division of AAM . Breaking Through on Biosimilars . Delivering more-affordable , innovative medicines to America ’ s patients . May , 2018 .
https :// biosimilarscouncil . org / wp-content / uploads / 2019 / 04 / Breaking-Through-on- Biosimilars-Biosimilars-Council- White-Paper . pdf ( accessed August 2020 ). 10 Conti R . Biosimilars : Reimbursement issues in your oncology practice . J Oncol Pract 2017 ; 13 ( 9 _ suppl ): 12s-14s . 11 Lyman G et al . American Society of Clinical Oncology Statement : Biosimilars in Oncology . J Clin Oncol 2018 ; 36 ( 12 ): 1260 – 5 . a reimbursement standpoint . In order to ensure appropriate reimbursement , practices have to tailor each dispensation to the plan ’ s coverage policy . This requires a great deal of coordination , at the level of each dispensation , between the prescribing provider , the authorization team , pharmacy , nursing , and others ; any failure points in this routine and laborious process can lead to reimbursement denial .
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Payer landscape evolution is needed to support a more stable and long-term sustainable biosimilar pharmacoeconomic model . Such a model needs to support trickle-down economics that provide a benefit to all involved stakeholders , including patients and the providers . The generic market has achieved this , remains a long-term sustainable model for all stakeholders involved , and in many respects , can help us pave the path to a more just biosimilar economic model . 4 , 11
Conclusions Biologic therapy innovation , compounded by the increased utilization of these products , has exponentially increased the costs associated with biologic therapies . The patent expiration of several biologics provided an opportunity to increase market competition by introducing more product options . The FDA has put forth a strict and robust biosimilar development and approval process , which calls for comprehensive analytical as well as clinical studies to ensure biosimilarity . Several years of real-world biosimilar post-marketing surveillance and the continuously expanding body of clinical evidence further validate the safe and effective use of biosimilars nationally and abroad . The unsustainable , yet fast-increasing cost of health care in the US remains a top public concern . Biosimilars provide a very strong value proposition to help mitigate the increasing cost of health care . However , to reap that economic benefit , biosimilars must be used . Healthcare professionals have a duty to evaluate the safety and efficacy of biosimilars and enable biosimilar utilization where there is evidence supporting biosimilarity . hospitalpharmacyeurope . com | 2021 | 27