Biosimilars/Research
A positive outlook for the US biosimilars market
The US is keeping pace with the European pioneers of biosimilars approvals, reveals an article published in GaBI Journal [1].
Expanding access to trastuzumab biological treatments
The anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab is indicated for treatment of HER2-positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Often used in conjunction with chemotherapy, trastuzumab was originally approved as an intravenous (IV) formulation. Subcutaneous (SC) formulations were more recently approved for HER2-positive breast cancer in 2013 (Europe) [1] and 2019 (US) [2].
CADTH summarizes evidence on switching to etanercept biosimilars
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA), known today as CADTH, is an independent, not-for-profit organization responsible for providing Canada’s healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our healthcare system.
Relieving the economic burden on EU healthcare budgets: spotlight on IV trastuzumab and rituximab biosimilars
In an ageing society with increasing medical need, biological treatments have played a key role in reforming the management of cancer, autoimmune and certain preventable diseases. Yet, biological treatments impose a significant financial burden on the healthcare system and healthcare payers.
Characteristics associated with biosimilar use in Medicare recipients
What patient, physician and practice characteristics are associated with biosimilar usage for the biologicals filgrastim and infliximab was a question asked by researchers from the US [1].
Biosimilars in the treatment of psoriasis
A recent paper by Spanish dermatologists reviews the principles of biosimilarity and equivalence trials that have led to the approval of the available adalimumab biosimilars [1]. Given the current sophistication of the analytical processes, the need to include therapeutic equivalence trials for some drug classes might be eventually waived, but they are currently standard. Equivalence trials are designed to establish that the efficacy and safety of the biosimilar are similar to those of the reference biological, with a predetermined margin of equivalence that in psoriasis ranges from ±14% to ±18%. Lower margins would imply potentially unaffordable sizes of treatment groups. The primary endpoint of the study and the timing of the determination may or may not be the same as those used in the pivotal trials of the reference biological, but the number of patients included is intentionally lower; the statistical design of equivalence trials is currently the subject of active research. In many equivalence studies, biosimilars obtain response rates higher than those reported in the pivotal studies for the originator, probably because of the absence of a placebo arm, which would tend to raise researchers’ and patients’ efficacy expectations.
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.
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.
