Biosimilares

Biosimilares aprobados en Costa Rica

Biosimilares/General | Posted 03/09/2021

En Costa Rica, el organismo regulador encargado de aprobar medicamentos biológicos es el Ministerio de Salud.

Biosimilares e intercambiabilidad en oncología

Biosimilares/Investigación | Posted 03/09/2021

Investigadores de Brasil investigaron, desde una perspectiva farmacéutica, un gran problema de la actualidad, que es la intercambiabilidad de biosimilares [1].

New quality-range-setting method for biosimilarity assessment

Biosimilares/Investigación | Posted 10/09/2021

Spanish researchers present a new method for the estimation of quality range (QR) bounds based on the variance components to account for both between-lots and within-lots variability; variance components are computed by the maximum likelihood method using a linear random model [1]. The authors have called this method QRML to differentiate it from the currently used procedure based on one sample per batch. For this, the molecular weight (Mw) and dimer content (expressed as percentage) were used as critical quality attributes (CQAs). Real data from seven batches of a commercial bevacizumab drug product were used.

Interactive map for interchangeable biosimilars

Biosimilares/General | Posted 10/09/2021

US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.

Glosario de términos principales

Biosimilares/General | Posted 10/09/2021

Desde el lanzamiento del primer biosimilar en Europa en abril de 2006, se ha debatido de manera reiterada sobre el uso adecuado de la terminología relativa a los medicamentos biológicos, principalmente en inglés.

Mabpharm gains approval for infliximab biobetter in China

Biosimilares/Novedades | Posted 10/09/2021

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 20 July 2021 that its partner, China-based Mabpharm, had received marketing approval from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for its infliximab ‘biobetter’ (CMAB008).

Conocimiento y percepciones de la denominación de biosimilares en EE. UU.

Biosimilares/Investigación | Posted 10/09/2021

La introducción relativamente reciente de los biosimilares en el mercado de los Estados Unidos y la nueva convención de denominación de los biofármacos impulsó la exploración de su impacto en la práctica clínica. La Administración de Alimentos y Medicamentos (FDA) publicó en 2017 una guía de denominación para productos biológicos y biosimilares nuevos, en la que se propone el uso de un nombre principal seguido de un sufijo de 4 letras carente de significado para facilitar la farmacovigilancia [1]. Para conocer la opinión de los proveedores de atención médica sobre este sistema, los investigadores evaluaron el uso, conocimiento, percepción y preferencias de esta convención de denominación en la práctica clínica [2]. Estudios previos permitieron formular la hipótesis de que los proveedores de atención médica mostraban carencias de conocimiento en torno a los biosimilares y que las opiniones sobre el uso del sufijo de 4 letras eran inconsistentes. El objetivo de este estudio era comprender el impacto de la reciente guía de denominación en la práctica clínica.

Clinical development of biosimilars in the oncology setting

Biosimilares/Investigación | Posted 17/09/2021

Biologicals as monoclonal antibodies (mAb) are highly complex products produced in living systems. They are included as treatment, combined with chemotherapy, for multiple common malignancies as cancer, in first- and second-line treatment regimens. However, the patient’s access to this type of treatment can be limited due to their high cost.

Clinical pharmacists have a critical role in increasing biosimilar uptake

Biosimilares/Investigación | Posted 17/09/2021

The increasing global burden of chronic diseases, including cancers, diabetes, autoimmune disorders, anaemia of chronic renal failure, rheumatoid arthritis, multiple sclerosis, blood disorders and others, underscore the importance of patients’ access to safe and effective treatments. Interestingly, the introduction of biologicals in the 1980s revolutionized the treatment of these chronic diseases with better prognosis, although high costs and limited patient access remain challenges. These biologicals are known by various names, including biopharmaceutical agents, biologicals, biological therapies, biological agents and biological response modifier therapy or immunotherapy. Biologicals are derived or manufactured from a living biological system. With the majority of originator biologicals losing patent protection and the emergence of biosimilars, the landscape of biologicals is facing many changes.

Biológicos sin patente/Biomimics aprobados en Bolivia

Biosimilares/General | Posted 17/09/2021

El organismo regulador encargado de aprobar medicamentos biológicos en Bolivia es la Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED.