Biosimilars
Study supports increased development of insulin biosimilars
Biosimilar insulins appear to be satisfactory in the treatment of both type 1 and type 2 diabetes and there is a strong case for increasing biosimilar insulin development, finds an editorial published in the Journal of Diabetes [1].
Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea
STADA and Xbrane Biopharma have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci, a biosimilar referencing ophthalmology drug, Lucentis (ranibizumab). In addition, Samsung Bioepis and Samil Pharmaceuticals will launch their biosimilar of Lucentis, Amelivu, in South Korea.
Malaysian hospital pharmacists’ perspective on and role in promoting biosimilars use
This survey study carried out by Mohd Sani N et al. aimed to evaluate Malaysian pharmacists’ perspectives of biosimilars and to determine factors associated with pharmacists successfully promoting their use.
Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada
In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively.
Survey demonstrates US pharmacist biosimilar knowledge gaps
Previous studies of stakeholder perceptions have primarily focused on physicians. However, pharmacists are key stakeholders in the use and adoption of biosimilars. The study carried out by Stevenson et al. sought to gain insights from US pharmacists about their knowledge and approach to the use of biosimilars.
DARS: advancing biosimilar development in the US
This article reviews the recent engagement of the Division of Applied Regulatory Science (DARS) in several current initiatives on utilizing pharmacodynamic (PD) biomarkers to demonstrate biosimilarity, potentially streamlining or negate the need for comparative clinical studies.
Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada
The bevacizumab biosimilar Vegzelma produced by Celltrion received full label approval from Canada’s drug regulator, Health Canada (HC), on 3 January 2023. Back in November 2022, bevacizumab biosimilar Aybintio by Samsung Bioepis had been launched in Canada by Organon, offering a more affordable treatment for Canadian patients suffering from certain types of aggressive cancer.
Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars
In January 2023, Alvotech announced that it has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). In addition, Dr Reddy’s Laboratories Ltd announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI. This is now ready for filing in markets such as the US and Europe.
Best-value biological selection making: more to consider than only price
A recent paper by Barbier et al. described the criteria to be considered when selecting best-value biological, emphasizing that more factors should be taken into account than only the price, and the authors proposed an updated approach - a model, and guidelines to assist healthcare professionals to make transparent and evidence-based decisions [1].
US PBMs add multiple Humira biosimilars to formularies
In the US it has been announced that several pharmacy benefit managers (PBMs) will be adding multiple biosimilar versions of AbbVie’s Humira (adalimumab) to their formularies in 2023.
