Biosimilars
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.
Trastuzumab non-originator biological approved in Russia
Russian biotechnology company Biocad announced on 20 January 2016 that the Russian Ministry of Health had approved the company’s trastuzumab non-originator biological, BCD-022. The drug is a non-originator biological of Roche’s breast cancer blockbuster Herceptin (trastuzumab).
Efficacy and safety of biosimilar infliximab compared to other biologicals in rheumatoid arthritis
In the paper by Baji et al. [1], the authors carried out a meta-analysis to compare the efficacy and safety of biosimilar infliximab and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab. The analysis compared the recommended doses of biological disease-modifying anti-rheumatic drugs (DMARDs) indicated in RA.
Safety concerns limit similar biologics uptake in India
How do concerns about the safety of domestic biologicals limit the uptake of ‘similar biologics’ in India? This is a question that author Malipatil tried to address in his review of similar biologics in India [1].
Differences between biosimilars and reference products
A review of glycosylated biosimilars approved in the European Union (EU) and Japan has highlighted structural variances between biosimilars and their reference products [1].
FDA advisers recommend approval of Celltrion’s infliximab biosimilar
US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Celltrion’s biosimilar version of Johnson & Johnson and Merck’s arthritis treatment Remicade (infliximab).
EMA accepts application for pegfilgrastim biosimilar
Sandoz, the generics division of Novartis, announced on 11 February 2016 that its regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).
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).
Pharmacovigilance for biologicals in The Netherlands
Escher is an independent regulatory research platform run by Netherlands-based research enabler TI Pharma. The group recently published a paper in the journal Drug Safety on the traceability of biologicals in clinical practice and adverse drug reaction (ADR) reporting [1]. This paper concludes that in The Netherlands brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.
Launch of partnership for biosimilars education and access
The Biosimilars Forum announced on 1 February 2016 the launch of a new biosimilars education initiative. The ‘Partnership for Biosimilars Education and Access’ will focus on raising awareness and encouraging access to biosimilars in the US.
