Biosimilars
FDA approves infliximab biosimilar Inflectra
The US Food and Drug Administration (FDA) announced on 5 April 2016 that it had approved the country’s second biosimilar Inflectra (infliximab).
EMA recommends approval of infliximab biosimilar Flixabi
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 April 2016 that it had recommended granting of marketing authorization for a biosimilar infliximab product (SB2).
Biosimilars of insulin glargine
Last update: 27 November 2020
Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.
European regulatory pathways for biosimilars
The European regulatory pathways for biosimilars were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.
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).
How the biosimilars market is changing
Access to high quality medicine at affordable prices without jeopardizing patients’ health is one of the key challenges in developed countries where rising life expectancy and growing average age puts pressure on national healthcare systems. Biosimilars represent a class of medicinal products that seem to be attractive in tackling this challenge. However, market acceptance of biosimilars in general is still low.
Biologicals: characteristics that make them unique and special
The unique characteristics of biologicals were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.
Biocon receives Japanese approval for insulin glargine biosimilar
India-based biologicals specialist Biocon announced on 28 March 2016 that it had received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its insulin glargine biosimilar.
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.
Biosimilars: a new challenge in the current pharmacology
In a review of biosimilars in rheumatology author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain discuss issues surrounding biosimilars*.
