Biosimilars
Advances for Formycon and Alteogen’s eye disease biosimilar candidates
In March 2021, Formycon confirmed the resubmission strategy for their Lucentis® (ranibizumab) biosimilar candidate (FYB2010) in the US. In addition, Alteogen announced the completion of its phase I clinical trial of Eylea® (aflibercept) biosimilar (ALT-L9). Both of these biological drugs are used to treat conditions leading to the loss of vision.
Adalimumab biosimilar FKB327 causes less pain than originator
Fujifilm Kyowa Kirin Biologics’ adalimumab biosimilar FKB327 has been found to cause less injection-site pain compared to the reference product, according to data from more than 1,001 subjects and patients [1].
Biosimilars regulation, clinical trials, approval and adverse events in Malaysia
Compared to chemical drugs, biologicals are more expensive because of their complicated manufacturing processes. Patients often use biologicals for long-term therapy, which may exert huge budgetary pressure on healthcare systems. One alternative solution to address this issue is to use biosimilars that are similar to the originator biologicals, with no clinical differences in terms of quality, efficacy, safety and immunogenicity. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) approved the country’s first biosimilar, somatropin, in 2010. Since then, the number of approved biosimilars and clinical trials on biosimilars continue to rise. With increased use of biosimilars, an increased number of adverse events (AEs) is expected because like any other biological, they may elicit immunogenic reactions.
FDA accepts application for adalimumab biosimilar CHS-1420
US-based Coherus BioSciences (Coherus) announced on 17 February 2021 that the US Food and Drug Administration (FDA) had accepted the application for their proposed adalimumab biosimilar CHS-1420.
Biosimilars of ustekinumab
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.
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.
