Biosimilars
Etanercept biosimilar injection pen, YLB113, convenient and easy to use
A study of an injection pen formulation of the etanercept biosimilar YLB113, which is manufactured by the Japanese firm YL Biologics, finds it to be convenient and easy to use and convenient among patients with rheumatoid arthritis [1].
Samsung Bioepis and Eden Biologics announce new biosimilars trials
In early 2021, Samsung Bioepic and Eden Biologics announced advances in the clinical trials of their respective ustekinumab and denosumab biosimilars.
Australian and Indian approval for teriparatide products
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and the Drug Controller General of India (DCGI) has approved a teriparatide ‘similar biologic’.
Biosimilars of aflibercept
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.
Biosimilars in Europe: prescriber survey
A survey of European prescribers reveals a significant increase in familiarity with biosimilars since 2013 [1]. In addition, prescribers increasingly believe they should always have control of treatment decisions, including those to switch to a biosimilar.
Argentina approves bevacizumab similar biological medicine Zutrab
The Argentina-based Richmond Laboratory (Laboratorios Richmond) announced on 19 March 2021 that it had gained approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) for its similar biological medicine (medicamento biológico similar) Zutrab (bevacizumab).
EC approval for insulin aspart biosimilar Kixelle
The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.
Public health impact of using biosimilars and relevance of automated follow-up
Biological reference drugs and biosimilars have highly complex structures. Biosimilars need to demonstrate their biosimilarity during their development but unpredictable variations can remain, such as micro-heterogeneity. The healthcare community may raise questions regarding the clinical outcomes induced by this micro-heterogeneity. Indeed, unwanted immune reactions may be induced for numerous reasons, including product variations. However, it is challenging to assess these unwanted immune reactions because of the multiplicity of causes and potential delays before any reaction. Moreover, safety assessments, as part of preclinical studies and clinical trials, may be of limited value with respect to immunogenicity assessments because they are performed on a standardized population during a limited period. Real-life data could therefore supplement the assessments of clinical trials by including data on the real-life use of biosimilars, such as switches. Furthermore, real-life data also include any economic incentives to prescribe or use biosimilars.
Pelmeg developed with aid of regulatory reform
The development of Pelmeg, a biosimilar of pegfilgrastim, revealed flexibility in the regulatory guidelines as they were superseded by state-of-the-art science, a study uncovers [1].
IVM releases toolbox on how to switch patients to insulin biosimilars
The Dutch Instituut voor Verantwoord Medicijngebruik (Institute for Responsible Medicines Use, IVM) has released a toolbox for healthcare providers on how to switch patients to insulin biosimilars.
