Reports

Impact of biosimilar competition in Europe in 2021

Home/Reports | Posted 25/02/2022

A study of 23 European biosimilar markets has found that biologicals are an increasingly important component of pharmaceutical expenditure, due to their efficacy as treatments for complex conditions.

Market outlook for biological medicines in Brazil 2016‒2025

Home/Reports | Posted 18/02/2022

In a report on the role of biosimilars in health care by Professor Dr Claudio Tafla of the University of São Paulo studied the market growth outlook from 2016 to 2025 for biological medicines. Biological medicines currently represent the pharmaceutical industry's largest source of innovation.

Pharmaceutical market of biological and biosimilar medicines in Brazil

Home/Reports | Posted 11/02/2022

According to a report entitled ‘The role of biosimilars in health’ by Professor Dr Claudio Tafla, a physician specializing in emergency medicine from the Pontifical Catholic University of São Paulo in Brazil, biological medicines consume around 40% of the federal public budget for the purchase of medicines in pharmaceutical assistance in the Unified Health System (Sistema Único de Salud, SUS), with rheumatoid arthritis being responsible for the greatest consumption of these resources [1].

Benefits of innovative biologicals and biosimilars for patients and health systems

Home/Reports | Posted 04/02/2022

A report carried out by several authors showed that if the launch of biotechnological drugs unleashed controversy at the time due to their novelty, those of biosimilars were even greater. Fifteen years after the launch of the first biosimilar and taking into account current regulations, the question remains as to whether they represent opportunities or risks in terms of safety, effectiveness and costs for patients, physicians and health systems. The challenges are to educate and communicate in a broad and sustained manner about scientific innovation in pharmaco-biology, the value of innovators, and the evidence of effectiveness and safety of biosimilars [1].

Key considerations for PD biomarkers in evaluating biosimilarity

Home/Reports | Posted 17/12/2021

Criteria for PD biomarkers intended to support a demonstration of biosimilarity are inherently different from criteria for surrogate biomarkers used to support new drug approvals.

The ‘positioning’ of PD biomarkers in evaluating biosimilarity

Home/Reports | Posted 10/12/2021

As comparative clinical studies can be costly and time consuming, the US Food and Drug Administration (FDA), is currently conducting research to inform the agency’s thinking on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. This, according to the agency could either streamline or negate the need for comparative clinical studies.

The role of PD biomarkers in biosimilarity

Home/Reports | Posted 03/12/2021

During the DIA Biosimilars Conference 2021 a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ was given by Dr Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA). In this presentation, Dr Stein outlined the role that pharmacodynamic (PD) biomarkers have with respect to biosimilars [1].

PD biomarkers for biosimilar development and approval

Home/Reports | Posted 26/11/2021

At the DIA Biosimilars Conference 2021, Dr Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA), gave a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ [1].

Biosimilar launches and uptake expected to increase in the US

Home/Reports | Posted 22/10/2021

In a presentation given by Doug Long, the expected launches and increase in uptake of biosimilars for the US market were discussed.

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.

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 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

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.

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.

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.

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.

Comparison of authorization requirements for biological and biosimilar medicines

Home/Reports | Posted 27/08/2021

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.

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