The Argentine Group for Crohn's Disease and Ulcerative Colitis (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa, GADECCU) has released an updated position statement on biosimilars, particularly regarding the alternate use of innovative biological drugs and biosimilars during the same chronic treatment in patients with inflammatory bowel disease.
In 2021, the Argentinian Society of Gastroenterology (SAGE) and the Argentinian Federation of Gastroenterology (FAGE) jointly published a position statement on biosimilar drugs in gastroenterology. In that publication, they established their agreement with the regulatory aspects of biosimilars, but also raised some questions about the unregulated aspects [1].
After more than 15 years of experience in the use of biosimilars worldwide, there is broad consensus on the regulatory requirements for their approval. However, there are many important aspects related to the use of biosimilars in the chronic treatment of complex diseases, such as inflammatory bowel diseases, that are not yet regulated in current legislation and remain the subject of debate. These aspects include the switch from an innovative biological medicine to a biosimilar, the interchangeability between different biosimilars of the same innovative biological medicine, multiple switches, and automatic substitution.
In most cases, the additional information necessary to make decisions in these aspects is not obtained through controlled clinical trials, such as those required for drug approval, but from observational studies in real-life conditions. These studies are inherently heterogeneous in terms of important variables, such as patient characteristics, treatment regimens, and evaluation of therapeutic responses.
In Argentina, several biosimilars/off-patent biologicals of the same reference biological medicine are already available. As a result, healthcare professionals are faced daily with the possibility or need to decide whether to switch between these products during ongoing treatment. Making decisions about these changes is a professionally significant responsibility, as it affects patients with complex and serious illnesses.
For this reason, GADECCU considered it crucial to establish some key definitions that are used in this position statement.
- Medical switch: a resource used by physicians to optimize the benefits of a treatment due to a clinical need. It is generally implemented when a medication is ineffective or causes an adverse event.
- Non-medical switch: does not stem from a clinical need. It may be motivated by economic considerations (most of the time), patient preference, or supply policies.
- Automatic substitution: the practice of replacing one medication with another at the pharmacy level during dispensing, without notifying or seeking approval from the prescribing physician.
In a following article the detailed position statement issued by GADECCU will be described.
Editor’s comment
Readers interested to learn more about position statement on biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
ECCO position statement on biosimilars
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Argentinian gastroenterologist groups issued position statement on biosimilars use [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jun 2]. Available from: www.gabionline.net/biosimilars/general/argentinian-gastroenterologist-groups-issued-position-statement-on-biosimilars-use
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