manner . The document reviews 23 Q & As that tackle issues including :
Basics
• What is a biological medicine ?
• How are biological medicinal products made ?
• How are biological medicines different from ‘ classical ’ medicines ?
• What are biosimilars ?
• What does ‘ similar ’ mean ?
Quality and safety
• Is there any difference in safety between the biosimilar and the reference product ?
• Is switching between a reference medicine and a biosimilar medicine ( and vice versa ) safe ?
• Are biosimilars likely to cause more adverse reactions than the reference medicines ?
• Is there any difference in quality and efficacy between biosimilars and their reference medicines ?
• Is there evidence that the biosimilar medicine is at least as effective as the branded medicine in treating all the same conditions as the branded medicine ?
• Or has this just been assumed given its high similarity ?
Use of biosimilars
• Why have biosimilars been introduced ?
• Will I have the choice whether I will be prescribed the reference medicine or the biosimilar medicine ?
• If the reference medicine is withdrawn from the market , will the biosimilar be withdrawn as well ?
• Can I take a biosimilar medicine in exactly the same way as the reference drug ?
• Is there anything I should know about how to store a biosimilar medicine ?
For physicians , the European document includes 12 Q & As , emphasising concepts including : efficacy , safety , immunogenicity , interchangeability ,
Biosimilars have become a reality in the therapeutic arsenal and are here to stay
pharmacovigilance , traceability , adverse effects following switching , clinical trials conducted , approved indications and , finally , costs .
The FDA also offers a variety of patient and prescriber outreach materials , including graphics , drop-in content , and social media messages , to help promote understanding of biosimilars and interchangeable products . These materials include : videos , fact Sheets , infographics and stakeholder toolkits ( animated GIFs , website badges , print ads , info cards , twitter posts , LinkedIn / Facebook posts ).
It is important to promote awareness to patients as a group , and some patient organisations have been very active and proactive in this field . As an example , in 2018 , the Patients for Biologics Safety & Access ( PBSA ), a national US coalition of more than 20 patient advocacy organisations , recommended that the FDA provides better education about biosimilar drugs on their website dedicated to biosimilars . They suggested changes that would help provide more complete and robust policy and clinical elements and better assure that prescribers can effectively talk to their patients about the complex world of biosimilars . 12 Recommendations included :
• Define and differentiate biosimilars and biologics more clearly
• Define key terms such as bioequivalence , approval process , and similarity , throughout the website
• Provide more examples in plain language of the meaning of terms used in the biosimilar process
• Provide more information on the FDA approval processes for biosimilars and interchangeable products
• Emphasise the importance of the patient – doctor relationship as it relates to prescribing a biologic versus a biosimilar .
The key role of the pharmacist Pharmacists , as ‘ drug experts ’ are vital in the education and decision-making processes . In the first stages , they not only play key roles in making formulary decisions about biosimilars but also in educating health care administrators , providers , legislators , policymakers , payors , and patients about these products ; and conducting pharmacovigilance activities to ensure the safe use of biosimilars in their institutions . The ASHP ( American Society of Health- System Pharmacists ) has developed a discussion guide for health-system Pharmacists on biosimilars . 13
The APhA ( American Pharmacists Association ) has also produced a brochure to help pharmacists in their role of informing patients who are candidates to receive biologic and / or biosimilar medications . The information is designed to help them make informed decisions about their healthcare treatment options . Many other national associations have worked in this way , or mention the role of the hospital pharmacist in education in their position papers on biosimilars . 14
The pharmacist is in a key position to undertake this role . The physician usually provides the first information that patients receive about biologics / biosimilars in the context of their disease . At that time , patients could feel overwhelmed in assimilating all the information they will receive ( about disease and treatment ). Their interview with the pharmacist comes some time later when they might feel less anxious and stressed . They are likely to have had time to process some of the news and therefore doubts and / or questions might have arisen , and the pharmacist is in a privileged position to clarify , complete and provide reassurance regarding the information provided by the physician .
Conclusions The emergence of biosimilar medicines across Europe and the US brings the promise of much added value in healthcare . The prospect of more affordable options that are safe and effective provides opportunities for health systems to expand access to biologics for more patients , free up resources for investment in new areas , and bring relief to pressured healthcare budgets . The cumulative potential savings to health systems as a result of the use of biosimilars will impact positively all over the world . 3
Moreso , the introduction of biosimilars promotes pharmaceutical innovation , bringing to market improved versions of existing biologics ( bio-betters ), such as delayed forms ( for example , EPO ), more appropriate dosages ( for example , adalimumab ), and alternative administration routes ( for example , rituximab , trastuzumab ).
Information oriented and planned towards the different stakeholders is a key element that will become crucial to guarantee successful implementation of biosimilars in clinical practice .
Biosimilars have become a reality in the therapeutic arsenal and are here to stay .
References 1 Karateev D , Belokoneva N . Evaluation of physicians ’ knowledge and attitudes towards biosimilars in Russia and issues associated with their prescribing . Biomolecules 2019 ; 9 ( 2 ): 57 . 2 Declerk P et al . The language of biosimilars : clarification , definitions , and regulatory aspects . Drugs 2017 ; 77 ( 6 ): 671 – 7 . 3 Nick C . The US Biosimilars Act : Challenges facing regulatory approval . Pharm Med 2012 ; 26 ( 3 ): 145 – 52 . 4 Lamanna WC et al . Maintaining consistent quality and clinical performance of biopharmaceuticals . Expert Opin Biol Ther 2018 ; 18 ( 4 ): 369 – 79 . 5 IQVIA . The global use of medicine in 2019 and outlook to 2023 . www . iqvia . com / institute / reports / the-global-use-ofmedicine-in-2019-and-outlookto-2023 ( accessed July 2019 ). 6 Lyman G . Biosimilars : The future of sustainable cáncer care . https :// connection . asco . org / magazine / current-controversiesoncology / biosimilars-futuresustainable-cancer-care ( accessed July 2019 ). 7 Giuliani R et al . Knowledge and use of biosimilars in oncology : a survey by the European Society for Medical Oncology . https :// esmoopen . bmj . com / content / 4 / 2 / e000460 ( accessed July 2019 ). 8 Soler Rotllant F Módulo 5 - Comunicación con el paciente y comunicación interprofesional ; Curso Online “ El papel de los biosimilares en la oncología y hematología clínica . 9 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 July 2019 ). 10 US Food and Drug Administration . Patient and prescriber outreach materials . www . fda . gov / drugs / biosimilars / patient-and-prescriberoutreach-materials ( accessed July 2019 ). 11 European Commission . What I need to know about biosimilar medicines . Information for patients . 2016 . http :// ec . europa . eu / growth / toolsdatabases / newsroom / cf / itemdetail . cfm ? item _ id = 9066 ( accessed July 2019 ). 12 Patient groups call on FDA to provide more complete and robust biosimilars educational materials for prescribers . www . biosimilardevelopment . com / doc / patient-groups-callfda-provide-more-completerobust-biosimilars-educationalmaterials-prescribers-0001 ( accessed July 2019 ). 13 ASHP Advantage . A Health-System ’ s pharmacist guide to biosimilars . https :// ashpadvantagemedia . com / downloads / biosimcentral _ guidelines . pdf ( accessed July 2019 ). 14 APhA . Biosimilars basics for patients . www . pharmacist . com / biosimilar-basics-patients ( accessed July 2019 ).
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