Biosimilars
Mabpharm gains approval for infliximab biobetter in China
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).
Glosario de términos principales
Last update: 23 September 2022
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.
Interactive map for interchangeable biosimilars
US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.
New quality-range-setting method for biosimilarity assessment
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.
Biosimilars and interchangeability in oncology
Researchers from Brazil investigated, from a pharmaceutical perspective, a major problem of the present time, which is the interchangeability of biosimilars [1].
Biosimilars approved in Costa Rica
In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.
Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar
German-headquartered companies Formycon and Bioeq have announced a European marketing authorization application for their ranibizumab biosimilar, FYB201.
Biosimilar interchangeability and emerging treatment strategies for IBD
Biosimilar development and utilization, as well as non-biological oral agents with unique pathological targets, will continue to dominate efforts to improve patient access and reduce the overall cost of care as non-surgical treatments for Crohn’s disease and ulcerative colitis in adults and children. Therapeutic drug monitoring, combined with inflammatory biomarkers, have become the standard of care to assess effectiveness.
Human insulin ‘similar biologic’ InsuTrend launched in India
India-based company Anthem Biosciences (AnthemBio) announced that it has launched its human insulin ‘similar biologic’ InsuTrend in India.
Pharmacist-driven biosimilar substitution saves money
A study of pharmacist-driven substitution of brand-name biologicals with biosimilars has shown that this can lead to substantial cost savings in the setting of a community oncology practice.
