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22119008_l FDA approves pegfilgrastim biosimilar Ziextenzo posted 12/11/2019

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Dr...

Tanvex BioPharma’s filgrastim biosimilar comes under fire posted 12/11/2019

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infr...

20920796_l Bevacizumab ‘similar biologic’ Versavo launched in India posted 11/11/2019

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its b...

22119008_l EMA approval for Pegfilgrastim Mundipharma posted 25/10/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that...

Russian approval for non-originator dornase alfa posted 23/10/2019

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Rus...

 

Research

Clinical data requirements for biosimilars in the EU: immunogenicity comparability posted 12/11/2019

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case s...

Biosimilars regulation in Canada: state of play posted 12/11/2019

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, i...

Clinical data requirements for biosimilars in the EU: efficacy comparability posted 11/11/2019

The European Medicines Agency (EMA) uses a totality of evidence approach in its regulatory review process for biosimilar appr...

Clinical data requirements for biosimilars in the EU: PK and PD comparability posted 25/10/2019

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute f...

AA010964 Positive real-world data for etanercept biosimilar Benepali posted 25/10/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 9 October 2019 that it had presented positive r...

 

General

Biosimilars approved in Canada posted 13/11/2019

Last update: 8 November 2019In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic...

Biosimilars of bevacizumab posted 13/11/2019

Last update: 8 November 2019Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new bl...

Biosimilars approved in the US posted 13/11/2019

Last update: 4 November 2019In the US, a legal framework for approving biosimilars was established in 2009, via the Biol...

Biosimilars of epoetin alfa posted 12/11/2019

Last update: 4 November 2019Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA techno...

Biosimilars approved in Europe posted 28/10/2019

Last update: 25 October 2019In the European Union (EU), a legal framework for approving biosimilars was established in 2...

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