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Teriparatide biosimilar Terossa approved in South Korea posted 24/01/2020

South Korea-based Daewon Pharmaceutical has obtained regulatory approval to begin marketing and selling its teriparatide bios...

ST002293 Bevacizumab and teriparatide biosimilars launched in Japan posted 24/01/2020

Biosimilars for osteoporosis treatment teriparatide and for anticancer drug bevacizumab were launched in Japan in late 2019.

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...

 

Research

Swiss position statement on the use of biosimilars in IBD posted 24/01/2020

Experts from the Swiss Society of Gastroenterology have provided a position statement on the use of biosimilars in inflammato...

Real-life clinical effectiveness of Razumab in wet AMD posted 24/01/2020

The multicentre, retrospective RE-ENACT 2 study evaluated the real-world effectiveness of ranibizumab biosimilar, Razumab, fo...

Biocad announces positive rituximab results and plans to enter EU market posted 21/01/2020

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 21/01/2020

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 21/01/2020

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

 

General

Eli Lilly and Novo Nordisk launches lower-priced insulin options posted 24/01/2020

Originator insulin makers Eli Lilly and Novo Nordisk have both announced the introduction of additional reduced cost insulin...

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...