Biosimilars

Swiss position statement on the use of biosimilars in IBD

Biosimilars/General | Posted 24/01/2020

Experts from the Swiss Society of Gastroenterology have provided a position statement on the use of biosimilars in inflammatory bowel disease (IBD). The position paper summarizes key regulatory and clinical issues around biosimilars to help improve clinician and patient awareness.

Teriparatide biosimilar Terossa approved in South Korea

Biosimilars/News | Posted 24/01/2020

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

Eli Lilly and Novo Nordisk launches lower-priced insulin options

Biosimilars/General | Posted 24/01/2020

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

Bevacizumab and teriparatide biosimilars launched in Japan

Biosimilars/News | Posted 24/01/2020

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

Real-life clinical effectiveness of Razumab in wet AMD

Biosimilars/Research | Posted 24/01/2020

The multicentre, retrospective RE-ENACT 2 study evaluated the real-world effectiveness of ranibizumab biosimilar, Razumab, for the treatment of wet age-related macular degeneration (wet AMD). This report presents the results from a subgroup analysis of the RE-ENACT 2 study [1].

WHO prequalifies first biosimilar

Biosimilars/General | Posted 17/01/2020

The World Health Organization (WHO) has prequalified its first biosimilar – trastuzumab – in a move that the organization says, ‘could make this expensive, life-saving treatment more affordable and available to women globally’.

Samsung Bioepis and AffaMed to start trastuzumab trial in China

Biosimilars/News | Posted 17/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted approval for partners Samsung Bioepis and AffaMed Therapeutics (AffaMed) to start a phase III trial for their trastuzumab product, SB3.

Biocad announces positive rituximab results and plans to enter EU market

Biosimilars/Research | Posted 17/01/2020

Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for its rituximab non-originator biological Acellbia (BCD-020).

Positive trial results for Lannett’s insulin biosimilar

Biosimilars/Research | Posted 17/01/2020

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

NeuClone progress with ustekinumab and trastuzumab biosimilars

Biosimilars/Research | Posted 10/01/2020

Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced positive results from a trial of their trastuzumab biosimilar.