Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

Enterprises, European Biopharmaceutical; Watson, Keith D.; Acha, Virginia; Roediger, Alexander; Rembratt, Åsa; Hume, Edward; Bisordi, Fabio; Bruggen, Marloes van

doi:10.5639/gabij.2014.0304.043

Cited by 7 publications

(3 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The Biosimilar Medicinal Products Working Party (BMWP) reported in 2012 three different possibilities regarding the inclusion of bioequivalence data into the SmPC of biosimilar drugs. These possibilities ranged from not including any information at all up to only reporting the bioequivalence data supporting EMA's assessment [34]. Current practice about a Biosimilar's SmPC in Europe is to develop a document identical (with the exception of using the INN of the active substance instead of the tradename of the reference product [35]) to the SmPC of the reference product, thus excluding any bioequivalence data.…”

Section: Biosimilars' Smpcs and Immunogenicity Datamentioning

confidence: 99%

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically

et al. 2019

View full text Add to dashboard Cite

Objective: To evaluate whether the current case-by-case practice leads to sufficient reporting of immunogenicity-related information in the Summary of Product Characteristics (SmPCs) of biological products approved in the European market.Methods: Immunogenicity-related information was identified and extracted from a group of 73 biological drugs that complied with drug-selection criteria. Afterwards, thirteen dichotomous questions were proposed to evaluate whether any issues are being commonly neglected.Results: Most SmPCs (92%) do not have any recommendations on how to report immunogenicity-related adverse drug reactions by patients or healthcare professionals. Furthermore, 80% of SmPCs do not identify the assay used to assess the reported immunogenicity rates, while 81% do not address the possible impact of immunogenicity on their drug's pharmacokinetics. It was also identified that a group factor (i.e. older drugs' SmPCs) could be influencing how/which issues were being addressed by newerdrugs SmPCs. To transform SmPCs into useful tools when an immunogenic response occurs, a proposal on how to report immunogenicity-related information in the SmPCs of biological products is advanced. This tool can be used by patients, healthcare professionals, regulators and businesses to evaluate the information of SmPCs. Conclusions:Based on these results, a case-by-case strategy does not yield enough reporting across products and thus immunogenicity-related information should be reported in a systematic way. Further guidance about reporting immunogenicity-related information is required, else SmPCs will not be the basis of information for healthcare professionals on how to use a biological product safely and effectively.

show abstract

Section: Biosimilars' Smpcs and Immunogenicity Datamentioning

confidence: 99%

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Since the US Food and Drug Administration (FDA) has only distributed draft guidance on the naming of biological medicines [11] and biosimilar labelling [12,13], feedback from the pharmacists who prepare and dispense them is also important in determining how these drugs are regulated. In Europe, product labelling is seen as important to build user confi dence in biosimilars [14]. In response to concerns in Europe, the Alliance for Safe Biologic Medicines (ASBM) invited 3,525 pharmacists in the US to complete a survey that included questions related to the information that could be included in a label, such as whether or not the product was a biosimilar; what analytical/clinical data and clinical similarity data should be present; post-marketing…”

Section: Introductionmentioning

confidence: 99%

Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Reilly¹,

Schneider²

2016

GaBI J

View full text Add to dashboard Cite

Introduction: To date, the US Food and Drug Administration (FDA) has off ered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of biosimilar medicines. Study objective: To determine the opinions of pharmacists about labelling and naming of biosimilars. Methods: A total of 3,525 pharmacists in the US were invited to complete a survey on the naming and labelling of biologicals. Responses were received from 849 pharmacists, of which 401 completed the survey. Of the pharmacists who completed the survey, 60% worked in hospitals or the healthcare system, 40% worked in retail. Pharmacists were asked for their feedback on a recent FDA non-proprietary biologicals naming proposal. They were also asked what information they would like to see included in a biological product label in order to choose between multiple biosimilars and their reference products. Results: Of the 401 pharmacists who completed the survey, 68% responded that FDA should require a distinct non-proprietary scientifi c name for every biological product-originator or biosimilar-approved by them. A total of 77% of respondents thought that a manufacturer-specifi c suffi x should be included in the name of each biological product. Respondents considered the following as very important for label inclusion: clinical data to support whether or not the product was a biosimilar and whether or not the biosimilar and originator are interchangeable. Noting that the drug was a biosimilar was considered the most important; whether or not it was interchangeable was slightly less important. Conclusion: A total of 401 pharmacists (11.4% of all those invited) completed the survey. The respondents comprised of 241 hospital pharmacists (60%) and 160 retail pharmacists (40%). Of these the majority of total respondents (68%) think that originator biological and biosimilars should have distinguishable non-proprietary scientifi c names and 77% think the name should include a unique, distinguishing suffi x specifi c to the manufacturer for future product approval.

show abstract

“…The Biosimilar Medicinal Products Working Party (BMWP) reported in 2012 three different options for reporting of bioequivalence data in the SmPCs of biosimilar drugs. These options ranged from not including any information at all up to only reporting the bioequivalence data supporting EMA's assessment [4]. The decision that came from this discussion was that a Marketing Authorisation Holder must develop a document identical (with the exception of using the International Nonproprietary Name of the active substance instead of the tradename of the reference product [5]) to the SmPC of the reference product, thus excluding any bioequivalence data from the SmPCs and include it exclusively in the product's European Public Assessment Report (EPAR).…”

mentioning

confidence: 99%

Biosimilars: An Opportunity to Update the Product Information of Biological Drugs Regarding their Immunogenicity

et al. 2019

View full text Add to dashboard Cite

Running Heading: Biosimilars as an opportunity to update the Product Information of biological drugs One of the greatest theoretical clinical concerns regarding the development of biosimilars has been that post-translational protein modifications, even while antigen binding remains essentially unaltered, might result in detrimental immunogenicity. We recently demonstrated [1] that the Summary of Product Characteristics (SmPCs) of biological drugs, approved by the European Medicines Agency (EMA), are very heterogeneous regarding the issues related to immunogenicity that are addressed within these documents.A complementary analysis, using the methodology advanced in [1], to the EMA's documents "Procedural steps taken and scientific information after the authorisation" shows that 57% (30/69) of the biological drugs that have been authorized prior to 2012 did not update their SmPC at least once when it comes to information related to unwanted immunogenicity. These are surprising results given the advancements that have been seen in the field of immunogenicity assessment [2], namely in the development of more

show abstract

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

Cited by 7 publications

References 3 publications

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically

Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Biosimilars: An Opportunity to Update the Product Information of Biological Drugs Regarding their Immunogenicity

Contact Info

Product

Resources

About