Biosimilars/Research
Asian specialists' recommendations for off-patent biologicals in IBD
Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].
Arguments against Alberta’s plans to switch patients to biosimilars
In May 2019, the Canadian province of British Columbia introduced a policy of switching rheumatology patients to biosimilars [1]. Now, the province of Alberta is also considering plans to stop coverage of originator biologicals and switch patients to biosimilars for certain indications. The new policy, if introduced, will apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD) [2].
Tackling the challenge of safe automatic substitution of biologicals
The costs of biologicals are challenging the sustainability of pharmacotherapy. Affordable biosimilars are expected to trigger competition within the biologicals market. Increasing real-world experience on biosimilars and clinical switching studies have led to position papers supporting the interchangeability of biosimilars with their reference products under the supervision of the prescriber [1]. However, the uptake of biosimilars has been poor in Finland, since physicians have been reluctant to prescribe biosimilars, especially in the outpatient setting. One option to stimulate the uptake of biosimilars is the automatic substitution of biologicals at the pharmacy level.
Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501
Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life terminated in 2016 in the US [1]. However, in the US AbbVie has stated that, although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of biosimilars until January 2023 [2, 3].
Reasons and solutions for the high cost of insulin in the US
The most commonly used forms of analogue insulin cost 10 times more in the US than in any other developed country. In fact, the cost of insulin in the country has more than tripled in the past 10 years [1]. This has led to patients rationing their insulin; something that does not happen in other developed countries, but is common in the US.
Achieving fairer prices for generics and biosimilars
Access to safe, effective, quality assured, and affordable essential medicines and vaccines for all has been identified as key to achieving universal health coverage and financial protection. However, this is not always the case, according to Alessandra Ferrario and colleagues from the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Healthcare Institute, Boston, USA [1].
Failures when switching patients to biosimilar etanercept
A ‘real-world’ study on switching patients from the originator etanercept, Enbrel, to the biosimilar Benepali (SB4) investigated the reasons why some patients switched back to the originator [1].
Law and ethics of switching to biosimilars in Canada
With healthcare budgets in mind, governments and financial institutions across the globe are planning or implementing non-medical or ‘forced’ switches by cutting drug coverage for reference biologicals and funding only less expensive biosimilars. This is a subject fraught with issues related to both the law and the ethics of switching. Authors Blake Murdoch and Timothy Caulfield of the Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta, Canada, try to address how such issues might affect Canada [1].
Real-life clinical effectiveness of Razumab in wet AMD
The multicentre, retrospective RE-ENACT 2 study evaluated the real-world effectiveness of ranibizumab biosimilar, Razumab, for the treatment of wet age-related macular degeneration (wet AMD). This report presents the results from a subgroup analysis of the RE-ENACT 2 study [1].
Biocad announces positive rituximab results and plans to enter EU market
Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for its rituximab non-originator biological Acellbia (BCD-020).
Analytical similarity assessment of teriparatide biosimilar Terrosa
Terrosa and Movymia (both developed under the code name RGB-10), were the first biosimilars of Eli Lilly’s osteoporosis biological Forteo/Forsteo (teriparatide) in Europe. Gedeon Richter and Stada Arzneimittel gained European Commission approval for Terrosa and Movymia in January 2017 [1] and launched the biosimilars in August 2019 [2]. Meanwhile, RGB-10 was also approved in other countries, including Switzerland and Japan.
Positive results for Bio-Thera’s arthritis copy biologicals
China-based Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive results from a phase III trial of its Humira copy biological.
Positive trial results for Lannett’s insulin biosimilar
US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockbuster insulin product Lantus.
NeuClone progress with ustekinumab and trastuzumab biosimilars
Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced positive results from a trial of their trastuzumab biosimilar.
Pharmacists must be ready to take the lead on biosimilars
Pharmacists should take the lead in increasing the adoption of biosimilars in clinical practice, says a review of the implications of biosimilars for pharmacy practice. The review suggests that pharmacists in all settings can take a key role in advocating for biosimilars [1].
Use of pegfilgrastim copy biological Mecapegfilgrastim in neutropenia
Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].
Biosimilar education for Canadian nurses
In general, Canadian nurses are familiar with biosimilars. However, according to authors Sehdev et al., they may have knowledge gaps in their specific understanding, resulting in a significant unmet need for education.
Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis
Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].
Biologicals and biosimilar use in Asian patients with IBD
The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].
Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab
A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.
