1
Reportage
Biosimilars approved in Europe
In this brief report, the GaBI online website offers a review as of January 28, 2022, of the biosimilar medicines authorized by the European Commission in its territory. Thus, since the approval of Omnitrope (somatropin), the first product approved in the European Union (EU) as a biosimilar in 2006, to date, the European Medicines Agency (EMA) has recommended the approval of 84 biosimilars that could be classified into the following categories 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis-stimulating agent; 4) insulin; 5) follicle stimulating hormone; 6) parathyroid hormone; 7) tumor necrosis factor (TNF) inhibitor; and 8) monoclonal antibodies for use in the European Union.
GaBI online. January 2022.
https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2
Scientific article
Characteristics of Clinical Trials Evaluating Biosimilars in Cancer Treatment A Systematic Review and Meta-analysis
This work by researchers at Harvard University assesses the design characteristics of biosimilar clinical efficacy trials for cancer treatment and the evidence that biosimilar trials provide in the US regulatory environment. It is based on a meta-analysis and a systematic review of 31 studies of biosimilars indicated for the treatment of cancer (trastuzumab, rituximab and bevacizumab) and in which 12.310 patients who were included in the study had participated. It follows that, compared to the pivotal trials of the reference medicines, the studies provided by the biosimilars (available at the time of the analysis) were, on average, larger, more often a randomized clinical trial, and more frequently double-blind. It concludes that biosimilars are as effective as their reference products in all disease settings, suggesting that studies of biosimilars for cancer treatment are rigorously designed and show equivalent efficacy.
Bloomfield D, et al. February 2022. JAMA Oncology.
3
Report
Biosimilars in the new NHS: proposals for action
This report suggests 14 proposals for action to promote the use of biosimilar medicines in the National Health System (SNS) in the current post-pandemic context. It is a consensus document in which several experts from different disciplines have participated (academic, care, pharmaceutical management and policy fields and a representation of patients). The proposals try to put into practice recommendations of a more global nature that since mid-2020 various national and European institutions have suggested for the promotion of biosimilars. To do this, the group of experts used an extensive review of international experiences that have proven to be successful. The measures are presented in four blocks depending on the theme and range from specific incentives for the research, development and production of biosimilar medicines in the national territory, to the establishment of objectives, the use of incentives such as gainsharing or the carrying out of marketing campaigns. awareness.
BioSim. February 2022.
4
Report
Biosimilars in 2022: the US journey and the road ahead
Cardinal Health has released a report on the biosimilar journey in the US and what's to come. This entity believes that 2022 will be a turning point for biosimilars in the United States and estimates that biosimilars that are yet to arrive will generate 133 billion dollars in savings by 2025.
It found that for the first time in 7 years, oncology spending growth was below 10% thanks to the impact of biosimilars and new product launches. Additionally, in their survey of more than 320 oncologists, 100 rheumatologists, 100 ophthalmologists, 50 endocrinologists and primary care physicians treating diabetes, and 115 pharmacists, they identified that only ophthalmologists reported that less than half (40%) are “very familiar” with biosimilars. And, furthermore, outside the field of ophthalmology, more than 90% of specialists say they are "very familiar" or "somewhat familiar" with biosimilar therapies.
CardinalHealth. February 2022.
https://www.sciencedirect.com/science/article/pii/S0049017221002171?via%3Dihub
5
Scientific article
Perceptions of biosimilar medicines among Belgian outpatients
Despite the experience with biosimilars across Europe, their uptake remains low in Belgium. One of the potential factors limiting adoption in clinical practice is inadequate knowledge and lack of trust in biosimilars among patients. This study aimed to assess the level of knowledge and perceptions about biosimilar medicines among Belgian patients in outpatient care. From the survey, in which 657 patients participated, it appears that 58% of them knew that biosimilars are as safe and effective as the reference medicine, that the vast majority (68%) agreed with the transition to a biosimilar if their doctor prescribed it, than if a doctor proposed to change their current treatment from the reference medicine to their biosimilar almost all patients (95%) want their doctor to explain the decision and inform them. Furthermore, to learn more about biosimilars, Belgian patients prefer: brochures (41%) or Internet resources (35%), requiring information on safety and efficacy (78%), price and reimbursement (64%), and the clinical development process (56%) of the biosimilar.