Biosimilars/General

Biosimilars approved in Peru

Biosimilars/General | Posted 01/10/2021

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].

New Zealand to expand access to rituximab, possibly adalimumab

Biosimilars/General | Posted 01/10/2021

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.

Biosimilars approved in Costa Rica

Biosimilars/General | Posted 03/09/2021

In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.

Biosimilars approved in Uruguay

Biosimilars/General | Posted 24/09/2021

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).

Off-patent biologicals/Biomimics approved in Bolivia

Biosimilars/General | Posted 17/09/2021

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).

Glosario de términos principales

Biosimilars/General | Posted 10/09/2021

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.

Interactive map for interchangeable biosimilars

Biosimilars/General | Posted 10/09/2021

US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.

Biosimilars, innovation in the treatment of chronic disease

Biosimilars/General | Posted 27/08/2021

Biological therapies have meant a significant advance in the way of treating various chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis. However, they have brought with them high costs for health systems that have been channelled through supply programmes of this type of drugs, in the case of the Dominican Republic, through the High Cost Medicines Programme.

Biosimilars of insulin aspart

Biosimilars/General | Posted 27/08/2021

Last update: 27 August 2021

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins.

Biosimilars applications under review by EMA – July 2021

Biosimilars/General | Posted 30/07/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.