Position of CAEME on biological and biosimilar drugs in Argentina

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The pharmaceutical companies that comprise the Argentine Chamber of Medicinal Products (Cámara Argentina de Especialidades Medicinales, CAEME) consider that biosimilar medicines are necessary for the sustainability of the healthcare system and patient access to effective treatment.

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CAEME is a pioneer of the pharmaceutical industry in Argentina and Latin America, with more than 90 years of experience. CAEME represents pharmaceutical and biotechnology companies that develop and market innovative medicines in the country. Among the 41 member companies are Amgen, Merck, Pfizer, Roche and Sanofi.

In September 2019, in a position paper [1] on biological and biosimilar medicines, CAEME promoted the following initiatives aimed at:

  1. Promoting high standards of quality, safety and efficacy in the development of biologicals and biosimilars
  2. Deepening the regulatory framework, with a focus on regulations that establish in detail the requirements for the demonstration of biosimilarity, in line with international guidelines for high health surveillance, ensuring greater specificity in the way comparability studies are conducted
  3. Consider that the therapeutic decision should be made under the guidance of the treating physician
  4. Distinguish in ANMAT (National Administration of Medicines, Food and Medical Technology) Regulatory Framework that the approval of the registration does not necessarily imply the possibility of interchangeability and/or automatic substitution
  5. Establish differential regulation in processes and times for the evaluation and approval of biologicals and biosimilars that have been approved by authorities such as EMA, FDA, among others
  6. Promote the visibility and transparency of the processes of initial evaluation, drug approval, maintenance of registration and post-registration changes by ANMAT
  7. Strengthen the pharmacovigilance system
  8. Create a National Register of reference biological products and their respective biosimilars.
  9. Promote the technical-scientific training of the different actors in the management of reference biologicals and biosimilars in Argentina
  10. Promote a space for discussion of the aforementioned aspects with the active participation of doctors, patients, regulators and funders of the health system

The next article presents, through CAEME, the position of different organizations regarding biosimilars in the world and in Argentina.

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LATIN AMERICAN FORUM

The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. 

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Reference
1. Cámara Argentina de Especialidades Medicinales, CAEME. 2019. Posicionamiento sobre medicamentos biológicos y biosimilares [homepage on the Internet]. [cited 2021 Jun 24]. Available from: https://www.caeme.org.ar/wp-content/uploads/2019/10/Position-Paper-CAEME-Biologicosy-Biosimilares-2019.pdf?x56998

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