Home / Biosimilars

Biosimilars

News

FDA grants tentative approval for insulin treatment posted 25/08/2014

On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (L...

More biosimilars collaborations on the cards posted 25/08/2014

Collaborations for biosimilars are still in vogue, with the latest companies making deals being PlantForm Corporation (PlantF...

Coherus starts phase III biosimilar etanercept trial posted 18/08/2014

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 23 June 2014 the start of a global phase III trial...

Biosimilars deals coming thick and fast posted 14/08/2014

Biosimilar collaborations are still the latest fashion, with new deals being made between Cipla and Mabpharm, Strides Arcolab...

Biosimilar infliximab receives approval in Japan and Turkey posted 08/08/2014

South Korean biotechnology company Celltrion announced on 4 and 16 July 2014 that the company had received marketing approval...

 

Research

ECCO survey highlights lack of confidence in biosimilar mAbs posted 26/08/2014

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and...

Biosimilars in the treatment of chemotherapy-induced anaemia posted 14/08/2014

A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology a...

Switching and extrapolation of subsequent entry biologics in Canada posted 13/08/2014

The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed...

Biosimilar trastuzumab similar to Herceptin in non-clinical study posted 13/08/2014

Comparative non-clinical assessments of the proposed trastuzumab biosimilar PF-05280014 and the originator product (Herceptin...

Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity posted 01/08/2014

Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar p...

 

General

WHO proposal offers clarity for biosimilar nomenclature posted 20/08/2014

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biolo...

Biosimilars of cetuximab posted 16/08/2014

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor receptor (EGFR) and is used to...

Biosimilars of darbepoetin alfa posted 16/08/2014

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is...

Biosimilars approved in Japan posted 06/08/2014

Last update: 1 August 2014In Japan, the regulatory body for the approval of medicines, including biologicals, is the Min...

32 organizations agree biosimilars should have same names posted 06/08/2014

On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals...

Generics News Research General

more

Biosimilars News Research General

more