GADECCU (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa), the Argentine Group for Crohn's Disease and Ulcerative Colitis, after providing key definitions on medical switch, non-medical switch and automatic substitution [1] and considering all the scientific information available, has updated its position in March 2023 regarding the use of biological medicines in clinical practice.
The positioning focuses on the use of both innovative biological drugs and biosimilars together as part of long-term treatment for patients with inflammatory bowel disease. The following recommendations summarize their position:
1. Non-medical switching is justified under the following conditions:
- Only one (1) change (from an innovative biological to a biosimilar, or vice versa).
- Only in patients with stable disease, with clinically proven and validated remission by the prescribing physician.
- The decision to implement this medication change must be agreed upon between the physician and the patient; therefore, they do not endorse the automatic substitution of biological medications.
2. Non-medical switching is NOT recommended in the following situations:
- At the beginning of a treatment, during induction.
- In patients with active disease.
- When there is evidence or suspicion of immunogenicity reactions.
3. In the absence of consistent clinical data, the following are NOT recommended:
- Non-medical switching between biosimilars of the same reference biological product.
- Reverse switching, understood as the transition from an innovative biological product to a biosimilar and back to the innovative product, or vice versa.
- Multiple switches between the innovative product and its biosimilars.
4. As an exceptional case of point 2, and always with the authorization of the prescribing physician and the patient's consent, the Group would consider it acceptable to make a non-medical switch from an innovative drug to a biosimilar or vice versa. This switch would only occur if the medication the patient is currently receiving becomes unavailable due to supply issues related to the laboratory that produces or imports it. The purpose of this switch is solely to ensure that patients with active illnesses are not left without medication.
5. GADECCU wants to establish two aspects that it considers relevant for the use of biosimilar medications:
- GADECCU recognizes that this type of medication, due to undergoing a much shorter regulatory approval process compared to innovative biologicals, must necessarily contribute to the optimization of healthcare budgets through a significant reduction in product prices. Consequently, this will expand access to a larger number of patients for quality medications.
- Due to the rapid introduction of numerous biosimilars and innovative biological products in the pharmaceutical market, there is a perceived urgent need to strengthen and streamline the current National Pharmacovigilance System in general, and specifically for biological medicines.
Back in September 2019, the pharmaceutical companies that make up the Argentinian Chamber of Medicinal Specialties (Cámara Argentina de Especialidades Medicinales, CAEME) expressed its position regarding biological and biosimilar drugs, considering that biosimilar medications are necessary for the sustainability of the healthcare system and patients' access to effective treatment [2].
Editor’s comment
Readers interested to learn more about position statement in Latin America on biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications
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LATIN AMERICAN FORUM
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Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Ver el último artículo de cabecera: Actualización de la declaración de posición de GADECCU sobre los biosimilares !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. GADECCU presents a new positioning on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 14]. Available from: www.gabionline.net/biosimilars/general/gadeccu-presents-a-new-positioning-on-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Position of CAEME on biological and biosimilar drugs in Argentina [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 14]. Available from: www.gabionline.net/reports/position-of-caeme-on-biological-and-biosimilar-drugs-in-argentina
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