Biosimilars

Japan proving to be a favourable market for biosimilars

Biosimilars/General | Posted 20/05/2016

Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimilars makers.

Approaches to increase uptake of biosimilars in Spain

Biosimilars/Research | Posted 13/05/2016

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe approaches that have been introduced in Spain to try and improve uptake of biosimilars in the country [1].

Benepali wins Danish tender for etanercept

Biosimilars/General | Posted 13/05/2016

Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).

A strategic approach to increase uptake of biosimilars in Spain

Biosimilars/Research | Posted 06/05/2016

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe the strategic approach that has been introduced in Spain to try and improve uptake of biosimilars in the country [1].

Biosimilars applications under review by EMA – April 2016

Biosimilars/General | Posted 06/05/2016

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

Biosimilars/Research | Posted 29/04/2016

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

Biosimilars/News | Posted 29/04/2016

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

Biosimilars/General | Posted 29/04/2016

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

Biosimilars/General | Posted 22/04/2016

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

Biosimilars/Research | Posted 22/04/2016

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

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.