Reports

Biosimilars approved, launched or in development in the US

Home/Reports | Posted 15/10/2021

In a presentation based on the report by health information technology and clinical research company IQVIA ‘Biosimilars in the US 2020–2024: Competition, savings and sustainability’ biosimilars launched, approved or in development for the US market were discussed [1].

GMP certification requirements in Chile, Cuba and Venezuela

Home/Reports | Posted 08/10/2021

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

Home/Reports | Posted 08/10/2021

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.

GMP certification requirements in Central American countries

Home/Reports | Posted 01/10/2021

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

US opinion on prescription drug price and regulation

Home/Reports | Posted 01/10/2021

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 Andean Community countries

Home/Reports | Posted 24/09/2021

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.

US opinion on prescription drug affordability

Home/Reports | Posted 24/09/2021

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.

GMP certification requirements in Argentina, Brazil and Mexico

Home/Reports | Posted 17/09/2021

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.

GABiC proposes the use of biosimilars as strategy for innovation and sustainability

Home/Reports | Posted 10/09/2021

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

Home/Reports | Posted 03/09/2021

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.