Reports
GMP certification requirements in Chile, Cuba and Venezuela
The increasingly globalized nature of commerce allows manufacturers to outsource activities, such as procurement of raw materials overseas, where different regulatory requirements may exist. Thus, there is a need to ensure that the good manufacturing practices (GMP) guidelines adopted by the regulatory authorities (RAs) and international organizations (IOs) are harmonized and robust. A robust set of GMP guidelines helps in safeguarding public health by assuring the quality, safety and efficacy of the biopharmaceuticals [1].
US savings from biosimilars could exceed US$100 billion
At the AAM 2021 Annual Meeting, Mr Doug Long* of IQVIA delivered a presentation on US biosimilar market access, indicating savings over the next five years in the US as a result of biosimilars are projected to exceed US$100 billion.
US opinion on prescription drug price and regulation
Kaiser Family Foundation (KFF) research released the results of the KFF Health Tracking Poll (18–25 May 2021) in June 2021. The poll has revealed that many in the US believe drug prices are unreasonable [1].
GMP certification requirements in Central American countries
Before submitting documentation for the marketing authorization of a medicinal product in several countries in Latin America, there are several requirements that have to be taken into consideration
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.
