Biosimilars naming, label transparency and authority of choice – survey findings among European physicians

Abstract

Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating to their experience with these medicines in a 15-minute web-based survey which was carried out in the last quarter of 2013. Results: Of the physicians surveyed, 53% mistakenly felt that an identical non-proprietary name implies identical structure; 61% said that identical non-proprietary names imply that the medicines are approved for the same indications, which they may not be, and 24% said they recorded only the non-proprietary name of the biological product in the patient record. Conclusion:The responses of the European physicians demonstrate the need for distinguishable non-proprietary names to be given for all biologicals. Biosimilars, in contrast to generic drugs, have diff erent structures, may have a diff erent therapeutic profi le, and may not be approved for all the indications for which the reference product has been approved.

Challenges and Best Practices in Perspective

“…In line with the different national health systems, doctors and pharmacists might substitute different medicines with the same active substance . Previous studies have shown that prescribers often communicate only the international non-proprietary name (INN) in ADR reporting (Dolinar and Reilly 2014) . Merely indicating the INN in an ADR report can be misleading, though, as two different medicines (the original biological and the new biosimilar) may have the same non-proprietary scientific name .…”

Getting Familiar With Biosimilars

“…Based on a survey of 277 providers, the paper also pointed to a low level of understanding of biosimilars. A 2014 study from Europe, where there has been much more experience with the drugs, indicated that only half of providers have a basic understanding of the drugs (Dolinar & Reilly, 2014).…”

Regulatory considerations in oncologic biosimilar drug development

“…25 Importantly, 38% reported that they never consult an EPAR to gain additional information on a product, compared with only 19% who do so routinely. Approximately 43% of the surveyed physicians noted that they refer to EPARs only occasionally.…”

“…Thus, since the SmPC is the primary reference source of information, it should contain all the salient information on a biosimilar product. 25 Other agencies follow a different approach for labeling biosimilars. For example, the Swiss Medic Guidance for biosimilars recommends that information on both the reference product and the biosimilar be included in the label, and the data relevant to the biosimilar be easily identifiable.…”

“…24 Consistently, the majority of the European physicians participating in the ASBM survey agreed that they should retain sole authority in the substitution process, specifying that they found it "critically important" (24% of responders), "very important" (48%), and "somewhat important" (23%) to retain such authority. 25 Potential issues related to the safety and efficacy of biosimilars including immunogenicity (eg, due to the switch between different products), incidence of potential adverse reactions, and specific activity over time are related to the complexity of these biologic drugs and their production in biologic systems. Approval of biosimilars following strict EMA/FDA standards, production according to Good Manufacturing Practices, reliable supply chains, careful post-marketing surveillance, and clinical experience in their use may all contribute to build a strong foundation for a safe and effective substitution of reference products with biosimilars.…”