In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on 18 March 2014 in Brussels, Belgium, Dr Alessandro Armuzzi presented results of a survey of European Crohn’s and Colitis Organisation (ECCO) members [2]. The results of the survey highlight the lack of confidence ECCO members have in biosimilars and the need for continued education.
The European Medicines Agency (EMA) approved its first monoclonal antibody (mAb) biosimilar, infliximab (Inflectra, Remsima), in July 2013 for the same indications as the originator product Remicade [3]. The indications cover a range of autoimmune diseases, such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. These indications go beyond those studied for the biosimilar.
ECCO is a non-profit association with the aim of improving the care of patients with inflammatory bowel disease (IBD) in Europe.
Survey
In order to study whether IBD specialists were aware of biosimilars, ECCO carried out a survey among its members in 2013. The survey consisted of a 15-question anonymous web survey, for which ECCO members were randomly invited by email to participate.
A total of 307 ECCO members completed the survey, of which 68% worked in a university hospital and 87% had been autonomously prescribing mAbs for more than two years.
When asked how best to define a mAb biosimilar, most respondents (69.5%) realized that such a biosimilar was ‘similar’ but not identical to the originator biological. However, 19.3% believed it to be identical to the originator biological, 7.5% to be in the same class (like adalimumab and infliximab) and 3.6% did not know how to define a biosimilar mAb.
When asked about the advantages of a mAb biosimilar, the majority of respondents (89.4%) replied that it would be cheaper than the originator product. On the other hand, most (67.1%) also responded that the biosimilar could have a different immunogenicity pattern to the originator biological. While 14.6% said that the neurotoxicity of the biosimilar could be higher than the originator biological and 43.2% also said that they could work differently from the originator biological.
When respondents were questioned on how they thought mAb biosimilars differed from other available biosimilars, e.g. erythropoietin, growth factors, only 10.1% stated that there was no difference. On the other hand, 62.4% responded that mAb biosimilars were more complex compared to other biosimilars and therefore more at risk of ‘not being similar enough’. While 53.7% believed that they required more accurate post-marketing pharmacovigilance and 65.1% said that they required well-designed trials with validated endpoints in each medical speciality.
Substitution
On the subject of pharmacists’ automatic substitution of originator biologicals by biosimilars, 85% were not in favour of automatic substitution, although 18% would support such substitution for new prescriptions.
Interchangeability
When considering interchangeability of originator biologicals and biosimilars, most of the respondents (63.7%) said that they would not switch a patient onto a biosimilar mAb as there is no disease-specific evidence about their interchangeability and 8.3% would not do it because of the poor results from the SWITCH study between infliximab and adalimumab. Only 5.9% said that they would switch the patient, with a further 22.1% saying that they would also switch, but only after informing the patient in detail, ‘because of the limited data on the safety of the biosimilar’.
Confidence
When questioned as to whether they were confident about prescribing biosimilars, less than half (39%) of respondents felt confident. The majority (61%) of respondents were either not confident (32.7%) or only a little confident (28.3%) about prescribing biosimilars.
Dr Armuzzi concluded that IBD specialists are generally informed about biosimilars and see them as an opportunity to reduce costs. They also agree that biosimilars should carry a distinct International Nonproprietary Name (INN). However, they do not believe biosimilars to be interchangeable with the originator and are not confident about the use of biosimilars in clinical practice.
The use of biosimilars in Europe is expected to result in overall savings between Euros 11.8 billion and Euros 33.4 billion between 2007 and 2020, with largest savings expected for France, Germany and UK [4].
Conflict of interest
The speaker of the presentation [1] reported that he had received lecture fee(s) from: AbbVie, MSD, Chiesi, Ferring, Nycomed, Takeda and Otsuka. The author has also acted as a consultant for AbbVie, Hospira, Eli Lilly, MSD, and Takeda.
Editor’s comment
Readers interested to learn more about biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Top developments in biosimilars during 2013
Comparison of biosimilars guidelines
If you are interested in contributing a research paper in a similar area to GaBI Journal, please send us your submission here.
Related articles
ECCO position statement on biosimilars
References
1. Dolinar RO, Reilly MS. Biosimilars naming, label transparency and authority of choice – survey findings among European physicians. Generics and Biosimilars Initiative Journal (GaBI Journal). 20143;3(2):58-5.
doi: 10.5639/gabij.2014.0302.018
2. Armuzzi A. A clinician’s perspective on recent prescribers’ surveys. EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) Roundtable. Naming, transparency and traceability for biosimilars: does Europe need to act? 18 March 2014; Brussels, Belgium.
3. Thorpe R, Wadhwa M. Biosimilar monoclonal antibodies approved for use in the EU. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):9. doi:10.5639/gabij.2014.0301.013
4. Haustein R, de Millas C, Höer A, Häussler B. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4).120-6. doi:10.5639/gabij.2012.0103-4.036
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment