Biosimilars/Research

Law and ethics of switching to biosimilars in Canada

Biosimilars/Research | Posted 31/01/2020

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

Biosimilars/Research | Posted 24/01/2020

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

Biosimilars/Research | Posted 17/01/2020

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

Biosimilars/Research | Posted 10/01/2020

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

Biosimilars/Research | Posted 06/09/2019

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

Biosimilars/Research | Posted 17/01/2020

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

Biosimilars/Research | Posted 10/01/2020

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

Biosimilars/Research | Posted 13/12/2019

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

Biosimilars/Research | Posted 06/12/2019

Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].

Biosimilar education for Canadian nurses

Biosimilars/Research | Posted 29/11/2019

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.