Reports

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