Reports
Pharmaceutical market of biological and biosimilar medicines in Brazil
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
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
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
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
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
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
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
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
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.
