Reports
GMP certification requirements in Andean Community countries
Market authorisation of a medicinal product represents a major effort for the pharmaceutical industry with a detailed plan with all the steps that are involved in the process.
GMP certification requirements in Argentina, Brazil and Mexico
Marketing authorisation (MA) of a medicinal product is the process of reviewing and assessing the evidence to support that product, in relation to its marketing, finalized by granting of a licence to be sold.
US opinion on prescription drug affordability
In June 2021, non-profit organization, Kaiser Family Foundation (KFF) research, released the results of KFF Health Tracking Poll (18–25 May 2021) regarding public opinion on prescription drugs and their prices in the US.
GABiC proposes the use of biosimilars as strategy for innovation and sustainability
The commitment to biosimilars as a strategy to promote innovation and sustainability is what motivated the creation of the Argentine Quality Biosimilars Group (Grupo Argentino de Biosimilares de Calidad, GABiC) in 2019, made up of the companies Amgen, Gobbi Novag and Sandoz.
Biosimilars as a sustainable option for the health system in Argentina
The COVID-19 pandemic in Argentina has raised questions about its impact on highly complex medical treatments, which, because they are imported, are costly to the social security system, to the point that they make coverage unviable for many.
Comparison of authorization requirements for biological and biosimilar medicines
The development of biosimilar medicines presupposes a paradigm shift from the traditional model used with an innovative medicine. Meanwhile, for a new molecular entity, the evidence for its development is based on generating data confirming its safety and efficacy.
Use of biosimilars generates savings in the Spanish health budget of 2021
It is estimated that the national health system (Sistema Nacional de Salud, SNS) will be able to save €930 million due to the use of biosimilars in 2021, according to the results of the Budgetary Impact Analysis of Biosimilar Medicines in the SNS of Spain (2009–2022) [1].
Five main barriers to developing biosimilars
According to Dr Ash Ramzan, principal consultant at Woodley BioReg, there are five main barriers preventing biosimilars from reaching their full potential.
Position of CAEME on biological and biosimilar drugs in Argentina
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.
A few drugs account for most of Medicare Part B spending
Findings from an analysis carried out by KFF of Medicare* spending in 2019 found that most of the Medicare Part B** spending on drugs was on a relatively small number of drugs [1]. KFF is a non-profit organization that provides independent information on national health issues.
