The Biosimilars Resource Centre is an educational portal that helps healthcare professionals develop their knowledge of biosimilars through e-Learning modules and curated peer-reviewed content. By providing three UEMS-EACCME-accredited e-Learning modules and the latest research, hand-picked by editors, the Resource Centre aims to disseminate knowledge on biosimilars for rheumatologists, gastroenterologists and dermatologists.
Module 1 is available now. Module 2 and 3 are scheduled for September and December 2016. To keep up-to-date with the latest additions to the Resource Centre, you can sign up for our E-Alerts.
Access the courses here
About the courses
With three UEMS-EACCME-accredited e-Learning modules, learners can dive into the topic of biosimilars, increasing their understanding and knowledge for improved practical applications and outcomes.
Each e-Learning module takes 45 minutes to complete and is worth 1 UEMS-EACCME credit. The modules are accompanied by three freely downloadable slide decks that learners can share with peers (non-CME accredited). Up to five new peer-reviewed articles are added every month to complement the content.
Three expert guest editors act as independent expert reviewers, in line with UEMS guidelines, and curate the content of the three e-Learning modules.
A biosimilar is a biologic medicinal drug that is a copy of a drug made by another company. Biosimilars can be manufactured once the original drug’s patent has expired, and must go through approval processes that involve citing the original drug.
Unlike generics, biosimilars are not carbon copies of their originators. Because they are made of biological molecules, they are more complex, and typically 10 to 1000 times the size of the small molecules that constitute generic drugs, making it almost impossible to create an exact copy.
Biosimilars can cut the cost of treatments in a similar way to generics; this makes them economically as well as clinically important for healthcare systems and professionals. And this is reflected in the figures – the biosimilars market is set to soar to over $6 billion in the next five years.
Despite this, familiarity with and knowledge of biosimilars is generally low in the medical community, with 25% of doctors never having heard of them, according to one survey.
Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data
Elena Nikiphorou, Hannu Kautiainen, Pekka Hannonen, Juha Asikainen, Arto Kokko, Tuomas Rannio & Tuulikki Sokka pages 1677-1683Expert Opinion on Biological Therapy, Volume 15, Issue 12, 2015
Treating to target in established rheumatoid arthritis: Challenges and opportunities in an era of novel targeted therapies and biosimilars.
Woodworth TG, den Broeder AA.Best Practice & Research Clinical Rheumatology, Volume 29, Issues 4–5, August–December 2015, Pages 543–549
Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health
Braun J, Kudrin A.Biologicals, Available online 23 April 2016, In Press, Corrected ProofTopics: Immunogenicity, Infliximab (CT-P13), Manufacturing, Regulatory Affairs, Reports & Studies, Switching and Interchangeability, Usage & Applications
This month the article: Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health has been recommended by Prof. Shahzad, in order to have deep insight on multiple aspects of biosimilar infliximab (CT-P13). The article covers the following features:
- Comprehensive and concise review of available data related to switching from reference medicinal products (RMP) to biosimilar infliximab (CT-P13)
- Enlist the randomized clinical trials and observational studies for switchability of CT-P13 in many countries.
- Insight about ongoing registries and post marketing studies for evaluation of CT-P13.
- Spotlight on regularities agencies/countries stance on interchange and substitution of biosimilars.
Dörner T, Kay JNature Reviews Rheumatology 2015 Dec;11(12):713-24. doi: 10.1038/nrrheum.2015.110. Epub 2015 Aug 18.
Choy E, Jacobs IASeminars in Oncology. 2014 Feb; 41 Suppl 1:S3-14. doi: 10.1053/j.seminoncol.2013.12.001. Epub 2013 Dec 6.
Lutz Heinemann, PhD, Hootan Khatami, MD, Ross McKinnon, PhD and Philip Home, MA, DPhil, DM, FRCPDiabetes Technology & TherapeuticsTopic: Usage & Applications
L. Heinemann, P. D. Home, M. HompeschDiabetes, Obesity and MetabolismTopic: Regulatory Affairs
Paola Minghetti, Paolo Rocco, Francesco Cilurzo, Lucia Del Vecchio, Francesco Locatelli
Drug Discovery Today, Volume 17, Issue 1-2, January 2012, Pages 63 - 70Topic: Regulatory Affairs