Biosimilars/Research

Alvotech and Celltrion proceed with adalimumab and rituximab biosimilars

Biosimilars/Research | Posted 27/08/2021

Iceland-based Alvotech has reached the primary completion date in a switching study for its adalimumab biosimilar, AVT02, while Celltrion Healthcare has released real-world data on the safety and efficacy of its rituximab biosimilar, Truxima, supporting its use as a treatment for lymphoma.

Canadian study says drug formulary policies do not improve biosimilar uptake

Biosimilars/Research | Posted 30/07/2021

Traditional public drug programme formulary policies alone are not effective in affecting biosimilar uptake, according to a Canadian study published in JMCP [1]. 

Clinical trials begin for Bio-Thera’s golimumab copy biological

Biosimilars/Research | Posted 30/07/2021

China-based Bio-Thera Solutions (Bio-Thera) have begun a phase III clinical trial for BAT2506, copy biological of the anti-inflammatory molecule Simponi (golimumab).

Bioequivalence of MYL-1402O to EU- and US-reference bevacizumab

Biosimilars/Research | Posted 30/07/2021

The proposed bevacizumab biosimilar MYL-1402O demonstrated bioequivalence to European Union (EU)- and United States (US)-reference bevacizumab in a pharmacokinetic (PK) study of healthy adult male volunteers.

Biosimilars and availability of reference products

Biosimilars/Research | Posted 15/01/2021

A survey was carried out by the World Health Organization (WHO) in 2019‒2020 covering most current topics pertinent to biosimilars [1].

What drives negative perceptions of biosimilars?

Biosimilars/Research | Posted 23/07/2021

A study of patients taking biological drugs in New Zealand identifies a number of attributes associated with negative perceptions of biosimilars, including being female, seeking information online, and preferring innovator drugs [1].

Clinical trials begin for ustekinumab biosimilars

Biosimilars/Research | Posted 23/07/2021

Biosimilars firms BioFactura and Alvotech announce the start of clinical trials for their Stelara (ustekinumab) biosimilars, named BFI-751 and AVT04, respectively. 

Switching to biosimilars safe and effective in IBD patients

Biosimilars/Research | Posted 16/07/2021

Multiple adalimumab biosimilars are now approved for use in inflammatory bowel disease (IBD). In fact, to date, 29 June 2021, there are 10 adalimumab biosimilars approved in Europe [1]. However, despite their approval, effectiveness and safety data in IBD remains scarce, according to authors from the UK and The Netherlands [2].

Biosimilars in Spain: balance between innovation and health public expenditure

Biosimilars/Research | Posted 16/07/2021

Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised. 

Biosimilars in Japan: an overview

Biosimilars/Research | Posted 09/07/2021

No regulations on interchangeability exist in Japan and switching between a reference product and biosimilar is often impractical, according to a letter recently published in The Lancet Oncology [1].