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News

20920796_l Trastuzumab biosimilar Herzuma approved in Canada posted 20/09/2019

South Korean biotechnology company Celltrion announced on 10 September 2019 that Health Canada had approved its trastuzumab b...

China approves new formulation of etanercept copy biological Yisaipu posted 20/09/2019

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

Teriparatide biosimilar Terrosa launched in Europe posted 17/09/2019

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa i...

Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled posted 17/09/2019

As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus o...

Herzuma gains Japanese approval for three-week cycle method posted 17/09/2019

South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and...

 

Research

Screening protein surface biosimilarity of rituximab using aptamers posted 20/09/2019

Among the many features needed to prove sufficient biosimilarity to a licensed drug produced in living organisms, is coherenc...

Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients posted 17/09/2019

The arrival of biosimilars represents more affordable alternatives for patients in several countries, increasing their access...

20920796_l More positive phase III results for rituximab biosimilar ABP 798 posted 17/09/2019

Biotech giant Amgen, and its partner Allergan, announced on 22 August 2019 positive data from a ‘top-line’ phase III study of...

Switching from reference to biosimilar infliximab in ankylosing spondylitis patients posted 17/09/2019

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that affects the spine and the sacroiliac (SI) joints...

Positive results for Bio-Thera’s arthritis copy biologicals posted 06/09/2019

Immune specialists Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive...

 

General

UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars posted 20/09/2019

The largest insurer in the US, UnitedHealthcare, has announced it will preferentially cover Amgen’s biosimilar cancer treatme...

Canadian IBD charity updates biosimilar position statement posted 17/09/2019

On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilar...

Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal posted 06/09/2019

After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbr...

AB004665 Momenta drops Humira biosimilar development posted 30/08/2019

Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they re...

Australia approves three biosimilars in first half of 2019 posted 23/08/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilar...