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.

Quebec announces biosimilar switching policy

Biosimilars/General | Posted 30/07/2021

Quebec, Canada has announced a biosimilar switching policy, which is expected to generate annual savings of CA$100 million at its conclusion in 2022.

Biosimilars as a sustainable alternative for complex diseases

Biosimilars/General | Posted 23/07/2021

The use of ‘similar biotherapeutic’ products and ‘biocomparable’ medicines, as biosimilar medicines are named in Colombia and Mexico, respectively, offer a sustainable alternative for health systems, leading to significant savings for payers and health institutions, as well as market opening. Biosimilars thus provide a fair competitive solution.

PANLAR issues consensus statement on biosimilars

Biosimilars/General | Posted 16/07/2021

PANLAR presented its position on biosimilar medicines at its own congress in Argentina. Via the consensus statement, the PANLAR specialists seek to demonstrate the efficacy, pharmacovigilance, regulation, quality and safety of biosimilar medicines.

Diferencias entre los medicamentos genéricos y los biosimilares

Biosimilars/General | Posted 16/07/2021

Medicamento biosimilar se usa para referirse a aquel medicamento biológico que ha demostrado ser altamente similar al medicamento de referencia, en cuanto a sus propiedades físicas, químicas y biológicas, habiendo esto sido demostrado por ejercicios comparativos analíticos y clínicos rigurosos.