Informes

Key considerations for PD biomarkers in evaluating biosimilarity

INICIO/Informes | 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

INICIO/Informes | 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

INICIO/Informes | 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

INICIO/Informes | 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

INICIO/Informes | 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

INICIO/Informes | 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].

Requisitos de certificación de BPF en Chile, Cuba y Venezuela

INICIO/Informes | Posted 08/10/2021

La naturaleza cada vez más globalizada del comercio permite a los fabricantes subcontratar actividades, como la adquisición de materias primas en el extranjero, donde pueden existir diferentes requisitos regulatorios. Por lo tanto, existe la necesidad de garantizar que los lineamientos de las buenas prácticas de fabricación (BPF) adoptados por las autoridades regulatorias (AR) y organizaciones internacionales (OI) estén homologados y sean robustos.  Una serie de lineamientos robustos sobre las BPF contribuye a salvaguardar la salud pública garantizando la calidad, seguridad y eficacia de los productos biofármacos [1].

US savings from biosimilars could exceed US$100 billion

INICIO/Informes | 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

INICIO/Informes | 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].

Requisitos de certificación de BPF en países centroamericanos

INICIO/Informes | Posted 01/10/2021

Antes de presentar la documentación para la autorización de comercialización de un medicamento en varios países de Latinoamérica, hay varios requisitos que hay que tener en cuenta.