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.
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.
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.
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.
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) .
According to Dr Ash Ramzan, principal consultant at Woodley BioReg, there are five main barriers preventing biosimilars from reaching their full potential.
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.
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 . KFF is a non-profit organization that provides independent information on national health issues.
During a press conference held on 14 November 2020, ‘A new generic medicines market’ strategy was revealed, with which ’the Health and Economic Secretaries will strengthen the companies producing generic medicines, through the linking mechanisms and technological tools, based on the principles of innovation, transparency, competitiveness and legality’ fostering firmly a wider and solid generic medicines market, for the benefit of Mexican nationals.
An analysis of Medicare* spending in 2019 was recently carried out by KFF, a non-profit organization that provides independent information on national health issues. The analysis found that most of the Medicare Part D** spending on drugs was on a relatively small number of drugs with only one manufacturer and without generic or biosimilar competitors .