Home / Biosimilars

Biosimilars

News

Pfizer gains Japanese approval for infliximab biosimilar posted 13/07/2018

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

FDA rejects botulinum toxin biosimilar from Evolus posted 06/07/2018

US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for appr...

FDA rejects Amgen’s trastuzumab biosimilar posted 06/07/2018

Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for...

Celltrion resubmits biosimilar trastuzumab to FDA posted 22/06/2018

South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing...

Etanercept biosimilars submitted to EMA and launched in Japan posted 15/06/2018

An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has bee...

 

Research

Biosimilars: implications for oncologists posted 13/07/2018

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granul...

Positive results for infliximab and trastuzumab biosimilars posted 13/07/2018

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzuma...

Biosimilarity testing using very low doses of rituximab posted 08/07/2018

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indicat...

Biosimilar insulins have same efficacy and safety as reference biologicals posted 08/07/2018

Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference b...

Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia posted 08/07/2018

Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131...

 

General

US pharmacies sue J&J for stifling infliximab biosimilars posted 13/07/2018

Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US Distr...

Biosimilars of bevacizumab posted 13/07/2018

Last update: 13 July 2018Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new...

Biosimilars of epoetin alfa posted 13/07/2018

Last update: 13 July 2018Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technolog...

Biosimilars applications under review by EMA – June 2018 posted 13/07/2018

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A leg...

Biosimilars of etanercept posted 06/07/2018

Last update: 6 July 2018Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis fa...

Generics News Research General

more

Biosimilars News Research General

more