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 .
A letter of intent on cooperation in biotechnology has been signed between India and Colombia, which could include collaborations on vaccines, biosimilars, and medical devices.
In Paraguay, the regulatory body responsible for the approval of biological drugs is the National Directorate for Sanitary Surveillance (Dirección Nacional de Vigilancia Sanitaria, DINAVISA).
In Cuba, the regulatory body responsible for approving biological drugs is the Center for the State Control of Medicines, Medical Equipments and Devices (Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, CECMED).
China has approved many more copy biologicals in the last three years. A move which, according to Pharmaceutical Technology, is thought could be due to the introduction of new guidelines for the products.
In Peru, the regulatory body responsible for approving biological drugs is the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health (MINSA) which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants .
New Zealand’s Pharmaceutical Management Agency, Pharmac, has announced a decision to expand access to rituximab and has launched a proposal to expand access to adalimumab.
In Uruguay, the regulatory body responsible for the approval of biologicals is the Ministry of Public Health of Uruguay (Ministerio de Salud Pública de Uruguay, MSP).
In Bolivia, the regulatory body for the approval of biologicals is the State Agency for Medicines and Health Technologies AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud).
Desde el lanzamiento del primer biosimilar en Europa en abril de 2006, se ha debatido de manera reiterada sobre el uso adecuado de la terminología relativa a los medicamentos biológicos, principalmente en inglés.