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ST002293 CKD Pharma’s darbepoetin alfa biosimilar launched in Japan posted 18/01/2019

On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval...

EMA approval for bevacizumab biosimilar Zirabev posted 11/01/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 tha...

18794124_l Trastuzumab and agalsidase beta biosimilars launched in Japan posted 11/01/2019

Japanese firms have announced the launch of agalsidase beta and trastuzumab biosimilars in Japan on 28 November 2018.

Biosimilars launched in the US at a significant discount posted 14/12/2018

Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.

FDA approves first rituximab biosimilar Truxima posted 07/12/2018

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-ab...

 

Research

EMA continues to be open to alternative clinical development strategies for biosimilars posted 18/01/2019

In the European Union (EU) and other highly regulated markets, companies need to prove the similarity of proposed biosimilars...

Positive phase III results for rituximab biosimilar PF 05280586 posted 18/01/2019

Pfizer has presented positive phase III results for its rituximab biosimilar PF‑05280586 at the American Society of Hematolog...

Long-term follow-up of switching to biosimilar infliximab posted 18/01/2019

A study of long-term follow-up data after switching to biosimilar infliximab appears to show identical retention rates, accor...

Positive results for adalimumab and etanercept biosimilars from Sandoz posted 14/12/2018

On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etane...

Positive results for Chinese rituximab and trastuzumab copy biologicals posted 07/12/2018

Researchers from Shanghai Henlius Biotech have presented positive phase III study results for their rituximab [1] and trastuz...

 

General

Celltrion wins patent suit in Japan over trastuzumab biosimilar posted 18/01/2019

South Korean biotechnology company Celltrion announced on 5 November 2018 that it had won a patent suit in Japan involving it...

Biosimilars makers in Canada to launch patient support programme posted 11/01/2019

Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen...

WHO should finalize its BQ guidance posted 19/12/2018

According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance....

Biosimilars approved in Europe posted 19/12/2018

Last update: 14 December 2018In the European Union (EU), a legal framework for approving biosimilars was established in...

Biosimilars approved in Australia posted 19/12/2018

Last update: 14 December 2018In Australia, the legal framework for approving medicines was established via the Therapeut...