Biosimilars

New administration route for epoetin alfa biosimilar Binocrit

Biosimilars/News | Posted 22/04/2016

Sandoz, the generics division of Novartis, announced on 8 April 2016 that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (SC) route of administration for its epoetin alfa biosimilar Binocrit’s nephrology (kidney function) indication.

A multidisciplinary perspective on biosimilars

Biosimilars/Research | Posted 15/04/2016

A biosimilar is an officially regulated and approved copy of an originator biological therapy. Authors Khraishi et al. aimed to provide a comprehensive review of the biosimilar development process and multidisciplinary guidance on their potential therapeutic utility in clinical practice [1]. They discussed clinical developments in the introduction of biosimilars across the expert disciplines of gastroenterology, nephrology, oncology and rheumatology, and from a payer perspective. They highlight a common need for ongoing pharmacovigilance, robust head-to-head clinical studies, and real-world data to establish the long-term risk-benefit profile of biosimilars.

Biosimilars: management of clinical issues

Biosimilars/Research | Posted 15/04/2016

How to manage clinical issues encountered with biosimilars was a topic discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.

BioOutsource launches ready-to-use biosimilarity assays

Biosimilars/News | Posted 15/04/2016

Sartorius Stedim BioOutsource (BioOutsource), a subsidiary of Sartorius Stedim Biotech, has launched a range of ready-to-use assays for testing biosimilarity. The assays are available for biosimilars of Hoffmann–La Roche/Chugai’s rheumatoid arthritis treatment Actemra (tocilizumab), Centocor’s psoriasis treatment Stelara (ustekinumab) and Novartis/Genentech’s age-related macular degeneration drug Lucentis (ranibizumab).

FDA approves infliximab biosimilar Inflectra

Biosimilars/News | Posted 08/04/2016

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

Biosimilars/News | Posted 08/04/2016

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

Biosimilars/General | Posted 08/04/2016

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

Biosimilars/Research | Posted 08/04/2016

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

Biosimilars/General | Posted 01/04/2016

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

Biosimilars/Research | Posted 01/04/2016

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.