Reports

Comparison of the cost of development of biologicals and biosimilars

Home/Reports | Posted 11/03/2022

The high cost of pharmaceuticals, in the case of biologicals, has a growing impact on healthcare costs worldwide.

Impact of COVID-19 pandemic on biologicals

Home/Reports | Posted 04/03/2022

A report released by data analysis firm IQVIA found that the COVID-19 pandemic has impacted certain segments of the biologicals market, but that, at least in Europe, this has not delayed the approval of new biosimilars [1].

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].