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Samsung Bioepis and AffaMed to start trastuzumab trial in China posted 17/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted a...

FDA approval for Amgen’s infliximab biosimilar Avsola posted 01/01/2020

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Admini...

Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial posted 01/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved...

Australia approves five biosimilars since June 2019 posted 01/01/2020

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimil...

Phase III trials started for bevacizumab and natalizumab biosimilars posted 01/01/2020

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

 

Research

Biocad announces positive rituximab results and plans to enter EU market posted 20/01/2020

Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for...

Positive trial results for Lannett’s insulin biosimilar posted 17/01/2020

US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockb...

NeuClone progress with ustekinumab and trastuzumab biosimilars posted 10/01/2020

Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced posit...

Analytical similarity assessment of teriparatide biosimilar Terrosa posted 10/01/2020

Terrosa and Movymia (both developed under the code name RGB-10), were the first biosimilars of Eli Lilly’s osteoporosis biolo...

Pharmacists must be ready to take the lead on biosimilars posted 13/12/2019

Pharmacists should take the lead in increasing the adoption of biosimilars in clinical practice, says a review of the implica...

 

General

18794124_l WHO prequalifies first biosimilar posted 20/01/2020

The World Health Organization (WHO) has prequalified its first biosimilar – trastuzumab – in a move that the organization say...

Non-originator biologicals approved in Russia posted 20/01/2020

Last update: 10 January 2020In Russia, the regulatory body for the approval of medicines is Russia’s Ministry of Health (Мини...

Canadian gastroenterologists issue biosimilar position statement posted 13/12/2019

The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had...

WHO launches insulin prequalification programme posted 09/12/2019

The World Health Organization (WHO) has announced a pilot prequalification scheme to certify biosimilar versions of insulin i...

Biosimilars of ranibizumab posted 09/12/2019

Last update: 6 December 2019Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as...

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