More Articles

Notice can be given before FDA approves biosimilar Policies & Legislation | Posted 16/06/2017

In a landmark decision by the US Supreme Court, biosimilars makers will be able to give notice to the originator manufacturer before the US Food and Drug Administration (FDA) has given final approv...

Comments on extrapolation in FDA’s interchangeability guidance from big pharma Guidelines | Posted 16/06/2017

19 May 2017 marked the end of the comment period on the US Food and Drug Administration’s (FDA) guidance on the interchangeability of biosimilars with their reference biologicals [1].

Biosimilar infliximab safe and effective in IBD Biosimilars/Research | Posted 16/06/2017

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].

Recommendations to enhance transparency of biosimilar labels Biosimilars/General | Posted 16/06/2017

On 6 June 2017, the European Association for Bioindustries (EuropaBio) announced that it had ‘developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars t...

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar Biosimilars/News | Posted 16/06/2017

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).

FDA targets rising drug prices by increasing generics competition Generics/General | Posted 16/06/2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb is advocating reducing drug costs by approving cheaper generics faster.

Celltrion making progress with biosimilars in China and Japan Biosimilars/News | Posted 16/06/2017

South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.

FDA approves two new Seroquel XR generics Generics/News | Posted 16/06/2017

The US Food and Drug Administration (FDA) has approved two generic versions of Astra Zeneca’s antidepressant Seroquel XR, which has a billion-dollar market in the US.