Experts from the steering committees of the Argentinian Society of Gastroenterology (SAGE), the Argentinian Federation of Gastroenterology (FAGE) and the Argentinian Group of Crohn's Disease and Ulcerative Colitis (GADECCU) have issued a joint position regarding the practical conditions for the clinical use of biosimilars indicated for inflammatory bowel diseases (IBDs), by discussing the most notable aspects related to the definition of a biosimilar drug, bio-similarity, non-comparable biological drugs or ‘intended copies’, approval requirements, extrapolation of indications, interchangeability, automatic substitution, non-medical switching, nomenclature, clinical standards regarding safety and efficacy, implementation of an efficient and appropriate pharmacovigilance system and the potential economic impact on the healthcare system .
Thus, SAGE, FAGE and GADECCU, have jointly expressed their opinion in favour of the introduction of biosimilars as a viable and safe alternative to the innovative biological products currently used in gastroenterology.
The following recommendations summarize their position regarding the management of biosimilar drugs in clinical practice:
1. First, they recognize the importance of introducing the use of biosimilars in the Argentinian pharmaceutical market. They also consider that the price of biosimilars available to the public should be significantly lower than the reference products, as this would translate into IBD patients having increased access to effective biological therapies and reduce drug expenditure in the healthcare system.
2. They recognize as biosimilar drugs those pharmaceutical products that have been approved in accordance with current regulatory requirements, excluding from this consideration non-comparable biologicals or intended copies. The choice of this type of drug over a biosimilar should be considered a high-risk approach.
3. They consider that the extrapolation of indications should not be granted automatically and that, as specified in the ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) provision regarding approval requirements, ‘there must be available scientific data supporting each of the indications’.
4. They agree that interchangeability is a specific regulatory attribute of a biosimilar, that should be granted exclusively by the regulatory authority based on clinical data, in addition to those submitted to demonstrate biosimilarity. Until the 'interchangeable biosimilar' status is granted by the regulatory authority, they discourage multiple switches between a reference product and the biosimilar, and switches between biosimilars of the same reference product in patients with IBD.
5. Switching from a reference biological to a biosimilar, or vice versa, will be accepted, provided that there is evidence from controlled clinical trials and/or real-life observational studies that justify it and when it has the endorsement of the prescribing physician and the patient's consent, both duly documented. Such evidence will be valid for that biosimilar, but not for another biosimilar of the same reference product.
6. Aware of the risks that could arise from an unconsulted substitution of the prescribed drug, any modification to the prescribed indication should be made after consultation and consensus between the patient and the attending physician.
7. Automatic substitution should not be feasible for biological products.
8. The shared decision between the physician and the patient regarding the choice of treatments is always fundamental for clear understanding of the objective to be attained and to achieve better adherence to the established guidelines.
9. They consider that there is a need to strengthen the current National Pharmacovigilance System by promoting an active participation of all parties involved in this system: regulatory agency, pharmaceutical laboratories, and health centres with professionals specialized in this field.
10. Unique and distinguishable identification should be maintained for innovative biological and biosimilar drugs during the prescription, dispensing and administration processes.
11. They suggest the inclusion of the specialist physician in the interdisciplinary team that participates in the procurement process of biological drugs with the aim of establishing fundamental technical specifications to provide patient safety.
The statement shares similarities with that of Crohn's and Colitis Canada, which published its position statement on biosimilars in September 2019 . The Swiss Society of Gastroenterology issued a more detailed statement, which also covers the regulatory process, extrapolation of indications and prescriptions .
Readers interested to learn more about biosimilars use in IBD are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence
First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society
Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar
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Readers interested in contributing a research or perspective paper in Spanish and/or English on biosimilar medicines in gastroenterology to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.
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Position of CAEME on biological and biosimilar drugs in Argentina
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1. Matar P, Cassella FI, Rainero GL, y col. Medicamentos biosimilares en Gastroenterología. Acta Gastroenterol Latinoam. 2021;Sup Esp:10-8.
2. GaBI Online - Generics and Biosimilars Initiative. Canadian gastroenterologists issue biosimilar position statement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/general/Canadian-gastroenterologists-issue-biosimilar-position-statement
3. GaBI Online - Generics and Biosimilars Initiative. Swiss position statement on the use of biosimilars in IBD [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/general/Swiss-position-statement-on-the-use-of-biosimilars-in-IBD
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