Biosimilars/General
Biosimilars on the horizon
Europe approved its first monoclonal antibody biosimilar, Inflectra/Remsima (infliximab), in September 2013 [1]. But how does the pipeline look for biosimilars and what will be the next biosimilar to be approved?
Biosimilars group launched in UK to improve biosimilars uptake
On 18 April 2016, the British Generic Manufacturers Association (BGMA) announced the launch of its expert sector group on biosimilars, the British Biosimilars Association (BBA).
US rheumatologists in favour of distinct names for biosimilars
Following the approval of the infliximab biosimilar Inflectra (infliximab-dyyb) the American College of Rheumatology (ACR) has issued a statement supporting the use of distinct names for biosimilars.
IPRF template for summary information for biosimilar reviews
The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB).
IGBA opposes WHO biological qualifier
The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [1]. However, not everyone agrees with their proposal.
US doctors poised to prescribe biosimilars
A survey of specialists in the US has found that nearly half of them expect to prescribe biosimilars to treatment-naïve patients.
Amgen sues Sandoz over etanercept biosimilar
Following the submission of application for approval of its etanercept biosimilar in the US, Sandoz is coming under fire from originator company Amgen.
Sandoz acquires EEA rights to infliximab biosimilar from Pfizer
Sandoz, the generics division of Novartis, announced on 12 February 2016 that it had acquired the rights for the development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA), which includes the 28 countries of the European Union (EU), plus Iceland, Liechtenstein and Norway.
FDA releases ‘Overview of Biosimilar Products’
As part of its ongoing mission to educate industry, the public and healthcare professionals about biosimilars, the US Food and Drug Administration (FDA) has released an online educational course for healthcare professionals.
Celltrion to use cloud-based technology for its biosimilars trials
On 20 January 2016, Korea-based biopharmaceutical company Celltrion announced that it had adopted Medidata’s Clinical Cloud to provide scalable technology for its biosimilars development programmes. The technologies include electronic data capture and management (Medidata Rave), medical coding (Medidata Coder) and randomization and trial supply management (Medidata Balance).
