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for another medicine that is expected to have the same clinical effect ”.
Australia has a clear position on interchangeability and the Pharmaceutical Benefits Advisory Committee performs the evaluation on interchangeability of biosimilars on a case-based method . Biosimilars can be “ a-flagged ”, meaning that pharmacists can make this substitution without the knowledge or consent of the patient ’ s specialist doctor , general
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practitioner or even the patient .
Regulations on biosimilar development and their approval vary among countries in Asia . Japan and South Korea have similar guidelines to EMA , whereas other countries such as China and India have their own regulations . In Japan , biosimilars are approved by the Pharmaceuticals and Medical Devices Agency ( PMDA ) but there are no regulations concerning interchangeability . Switching between a reference product and a biosimilar is decided by a physician and , while permitted , is often impractical , while substitution by the
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pharmacy is not allowed .
For economic reasons , the use of biologics in general remains very low in many Asian countries , although they are focusing on expanding their use in a larger part of the population . 18
The case of interchangeability in the US As previously described , the approach to interchangeability in the US is different to Europe and Asia . A manufacturer can apply for interchangeability designation of their biosimilar product at the same time as or after the marketing authorisation . The US FDA requires clinical studies to prove that multiple switching between the RP and biosimilar does not result in clinically significant differences ( in terms of safety and / or efficacy ) for patients . 2 , 4 , 24
An overview and additional information on all FDA-licensed ( approved ) biologics , including licensed biosimilar and interchangeable products and their RPs can be found in the Purple Book database . 25
What level of clinical evidence is required to support interchangeability ? To meet the additional designation of interchangeability in the US ( defined by the BPCIA ), applicants must submit clinical data ( additional to biosimilarity ), which demonstrate that any potential risk of safety or reduced efficacy from switching ( back and forth ) between the biological and the originator is not greater than the risk of using the reference biologic without such alternation or switching . This requires clinical trials to support the
In general , switching and substitution are largely dependent on national legislation and recommendations designation of interchangeability .
The FDA provides guidance with an overview of important scientific considerations for demonstrating the interchangeability of a biosimilar with the RP . 26
Current practice indicates that there are remaining challenges including the assessment of immunogenicity and the use of efficacy and safety endpoints in clinical interchangeability studies . 24
Conclusion With the development of biosimilars on the rise and many biosimilars already having reached the market , the concept of switching and interchangeability with the RP has become hotly debated .
To date , the US has taken a more conservative approach and a cautious outlook , whereas Europe has gained experience in monitoring a huge number of patients who have been switched from an RP to biosimilars .
The key to successful implementation of switching and interchangeability requires both education of a level of shared decision-making between physicians , pharmacists and other healthcare professionals .
References 1 European Medicines Agency . Biosimilars in the EU . Information guide for healthcare professionals . www . ema . europa . eu / en / documents / leaflet / biosimilars-eu-informationguide-healthcare-professionals _ en . pdf ( accessed Feb 2023 ). 2 US Food and Drug Administration . Biosimilars . www . fda . gov / drugs / therapeutic-biologics-applications-bla / biosimilars ( accessed Feb 2023 ). 3 Mysler E et al . Biosimilar-to-Biosimilar Switching : What is the Rationale and Current Experience ? Drugs 2021 ; 81:1859 – 79 . 4 Druedahl L et al . Interchangeability of biosimilars : A study of expert views and visions regarding the science and substitution . PLOS One 2022 ; 11 Jan . https :// doi . org / 10.1371 / journal . pone . 0262537 ( accessed Feb 2023 ). 5 Barbier L et al ; KU Leuven Belgium Research Group on Best-Value Biologicals . Biosimilar Interchangeability : Regulatory & Practical Considerations . www . bioprocessonline . com / doc / biosimilarinterchangeability-regulatory-practicalconsiderations-0001 ( accessed Feb 2023 ). 6 Barbier L , Vulto A . Interchangeability of Biosimilars : Overcoming the Final Hurdles . Drugs 2021 ; 81:1897 – 903 . 7 Azevedo V et al . Biosimilars : considerations for clinical practice .
Considerations Med 2017 ; 1:13 – 8 . 8 Afzali A et al . The Automatic Substitution of Biosimilars : Definitions of Interchangeability are not Interchangeable . Adv Ther 2021 ; 38 ( 5 ): 2077 – 93 . 9 The evolution of switching and substitution of biosimilars in Europe . https :// gabionline . net / reports / Theevolution-of-switching-and-substitutionof-biosimilars-in-Europe ( accessed Feb 2023 ). 10 International policies for interchangeability , switching and substitution of biosimilars . https :// gabionline . net / reports / Internationalpolicies-for-interchangeabilityswitching-and-substitution-ofbiosimilars ( accessed Feb 2023 ). 11 Hagen T . The Difference Between an Interchangeable Biosimilar and One That Isn ’ t . www . centerforbiosimilars . com / view / the-difference-between-aninterchangeable-biosimilar-and-onethat-isn-t ( accessed Feb 2023 ). 12 Canter B , Locke T , McClellan M . Revisiting Interchangeability to Realize the Benefit of Biosimilars . https :// healthpolicy . duke . edu / sites / default / files / 2021-11 / Revisiting % 20 Interchangeability % 20to % 20Realize % 20 the % 20Benefit % 20of % 20Biosimilars _ 0 . pdf ( accessed Feb 2023 ). 13 FDA . Interchangeable biological products . www . fda . gov / media / 151094 / download ( accessed Feb 2023 ).
14 National competent authorities ( human ). www . ema . europa . eu / en / partners-networks / eu-partners / eumember-states / national-competentauthorities-human ( accessed Feb 2023 ). 15 EMA . Biosimilar mediciens can be interchanged . www . ema . europa . eu / en / news / biosimilar-medicines-can-beinterchanged ( accessed Feb 2023 ). 16 Strand V , Goncalves J , Isaacs JD . Immunogenicity of biologic agents in rheumatology . Nat Rev Rheumatol 2021 ; 17 ( 2 ): 81 – 97 . 17 La Noce A . Biosimilars Interchangeability . Regional views aren ’ t interchangeable . www . pharmafocusasia . com / strategy / biosimilarsinterchangeability ( accessed Feb 2023 ). 18 Jorgensen K et al . Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab ( NOR-SWITCH ): a 52-week , randomised , double-blind , non-inferiority trial . Lancet . 2017 ; 389:2304 – 16 . 19 Glintborg B et al . A nationwide nonmedical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis : 1-year clinical outcomes from the DANBIO registry . Ann Rheum Dis 2017 ; 76:1426 – 31 . 20 Cohen HP et al . Switching Reference Medicines to Biosimilars : A Systematic Literature Review of Clinical Outcomes . Drugs 2018 ; 78 ( 4 ): 463 – 78 . 21 Tolonen HM et al . Is There Any
Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines ? A Systematic Review . BioDrugs 2021 ; 35 ( 5 ): 547 – 61 . 22 PBAC decision to approve biosimilars for pharmacy substitution is a safety concern for patients . www . medicinesaustralia . com . au / mediarelease / pbac-decision-to-approvebiosimilars-for-pharmacy-substitutionis-a-safety-concern-for-patients / ( accessed Feb 2023 ). 23 Biosimilars in Japan : an overview . https :// gabionline . net / biosimilars / research / biosimilars-in-japan-anoverview ( accessed Feb 2023 ). 24 Alvarez D et al . Interchangeability of Biosimilars : What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States ? BioDrugs 2020 ; 34:723 – 32 . 25 Purple Book . Database of Licensed Biological Products . https :// purplebooksearch . fda . gov / ( accessed Feb 2023 ). 26 Considerations in Demonstrating Interchangeability With a Reference Product ; Guidance for Industry . www . regulations . gov / document / FDA- 2017-D-0154-0061 ( accessed Feb 2023 ).
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