Home / Biosimilars

Biosimilars

News

FDA receives application for monoclonal antibody biosimilar posted 29/08/2014

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed th...

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...

 

Research

The future of biosimilar use and regulation in Latin America posted 29/08/2014

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigila...

ECCO survey highlights lack of confidence in biosimilar mAbs posted 29/08/2014

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 29/08/2014

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 29/08/2014

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...

 

General

Physicians believe biosimilars should have different names posted 29/08/2014

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

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...

Generics News Research General

more

Biosimilars News Research General

more