Biosimilars/General
Patients from Uruguay request that non-interchangeability of biotherapeutics be regulated
Patients demand guarantees that authorities will not make switches of biotherapeutic drugs solely for economic reasons and without considering the medical decision. This was expressed by the Uruguay Patients Alliance at the First National Biotechnology Forum. The main objective of this forum was to create a meeting place for the academic world, patients and health authorities in the field of biotechnology and innovation.
Concerns over Canada’s New Brunswick transition to biosimilars
Several biological medications whose patents have expired will no longer be covered under provincial drug plans of New Brunswick, Canada as of 30 November 2021. These are to be replaced by cheaper biosimilar versions; however, inflammatory disease associations have expressed concerns about the rapid transition.
AMD position statement on the use of biocomparables for psoriasis
The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.
Advances for biotech in Korea: Samsung Bioepis, Celltrion and LG Chem
Korean companies Samsung Bioepis and Celltrion have accelerated their penetration into the global market, with a total of 11 approvals in Europe and eight in the US. In addition, Korea’s LG Chem has expanded its presence in Japan and China. This growth follows increasing investment in the biotech sector from South Korea’s government and private pharmaceutical companies [1, 2].
Biosimilars approved in Chile
In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.
Biosimilars approved in Paraguay
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).
Biosimilars approved in Cuba
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).
Biosimilars approved in Peru
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 [1].
Biosimilars approved in Uruguay
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).
Biosimilars approved in Costa Rica
In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.
