HPE HPE Fresenius Kabi handbook - Page 8

There is no accepted worldwide naming convention for biosimilars and reference biologics with the manufacturer’s name would improve pharmacovigilance and reduce the risk of transcription and prescription errors, there are concerns that meaningful suffixes could become a proprietary item of the manufacturer associated with the product, and that through mergers and acquisitions the actual manufacturer might change while maintaining the original suffix. However, it is unlikely that prescribers, and to a lesser extent, patients, would remember the correct INN with a suffix including four random letters. Remembering the INN with the brand name or the manufacturer seems more likely. Other areas In Japan, biosimilars are referred to by the non- proprietary name of the reference biologic, followed by BS to denote biosimilar, the respective follow- on number and an abbreviation to reference the manufacturer. 9 Because the value of any distinguishable naming convention is dependent on its uptake by end-users, Health Canada intends to consult interested stakeholders to understand the compatibility of different schemes with the 8 | 2019 | hospitalpharmacyeurope.com electronic systems used for the prescribing, dispensing and tracking of biologic drugs. In the meantime, biologics in Canada are identified by brand name, common or non-proprietary name, and drug identification number. 10 India, China, Colombia, and Mexico have marketed intended copies of etanercept, and some Latin American countries and India have approved and marketed an intended copy from rituximab. There is no homogenous naming convention, but the fact that these intended copies often share the INN of the original biologic and its biosimilars underscores the need for a naming convention that allows their differentiation. 11 Conclusions Although there is a trend toward establishing differentiation between biologic originators and biosimilars through naming, there is still lack of global consensus. This lack of harmonisation could have direct implications on pharmacovigilance data, monitoring interchangeability, automatic substitution, and even reimbursement processes. 12 References 1 European Parliament and the Council of the European Union. Directive 2010/84/EU of the European Parliament and of the Council. https://eur-lex.europa. eu/LexUriServ/LexUriServ.do?ur i=OJ:L:2010:348:0074:0099:EN:P DF (accessed October 2018). 2 Grampp G, Felix T. Pharmacovigilance considerations for biosimilars in the USA. BioDrugs 2015;29: 309–21. 3 European Medicines Agency. Biosimilars in the EU. Information guide for heath professionals. www.ema. europa.eu/documents/leaflet/ biosimilars-eu-information- guide-healthcare-professionals_ en.pdf (accessed October 2018). 4 World Health Organization. Biological qualifier. An INN proposal. www.who.int/ medicines/services/inn/WHO_ INN_BQ_proposal_2015.pdf?ua =1 (accessed October 2018). 5 US Food and Drug Administration. Nonproprietary naming of biological products: A guide for industry. www.fda.gov/ downloads/drugs/guidances/ ucm459987.pdf (accessed October 2018). 6 World Health Organization. International nonproprietary names (INN) for biological and biotechnological substances. www.who.int/medicines/services/ inn/BioReview2016.pdf (accessed October 2018). 7 US Department of Health and Human Services Food and Drug Administration. Labeling for biosimilar products. Guidance for industry. www.fda.gov/downloads/ Drugs/GuidanceCompliance RegulatoryInformation/ Guidances/UCM493439.pdf (accessed October 2018). 8 Fernando-Lopez S. FDA draft guidance on the naming of biosimilars. BioDrugs 2015;29:323–5. 9 Mysler E et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int 2016;36:613–25. 10 Klein AV et al. Biosimilars: State of clinical and regulatory science. J Pharm Pharm Sci 2017; 20:332–48. 11 Macdonald JC, Hartman H, Jacobs IA. Regulatory considerations in oncologic biosimilar drug development. MAbs 2015;7:653–61. 12 Kos IA et al. The biosimilars journey: current status and ongoing challenges. Drugs Context 2018;7:212543.