Biosimilars
Biosimilars applications under review by EMA – April 2016
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Improving uptake of biosimilars in Spain
Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, investigated how efforts to improve the uptake of biosimilars in the country have been working.
Samsung Bioepis starts phase III trial for bevacizumab biosimilar
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis has started a phase III clinical trial for a biosimilar version of Roche’s cancer blockbuster Avastin (bevacizumab).
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.
Biosimilars: the clinical perspective
How biosimilars can be viewed from a clinical perspective was discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.
New administration route for epoetin alfa biosimilar Binocrit
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
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
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
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).
