Biosimilars/News
Positive EMA-CHMP opinion for SC infliximab biosimilar
South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).
Samsung Bioepis to supply Brenzys to Brazil under production development partnership
On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.
Trastuzumab biosimilar Herzuma approved in Canada
South Korean biotechnology company Celltrion announced on 10 September 2019 that Health Canada had approved its trastuzumab biosimilar Herzuma.
China approves new formulation of etanercept copy biological Yisaipu
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved Yisaipu, an etanercept copy biological as a pre-filled syringe.
Herzuma gains Japanese approval for three-week cycle method
South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved a three-week cycle method for its trastuzumab biosimilar, Herzuma (CT P6), in the treatment of breast cancer.
Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled
As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus on its own Botox biosimilar, DAXI. It aims to launch the product in 2020.
Mylan launches adalimumab biosimilar Hulio in Spain
US-based drugmaker Mylan announced on 9 July 2019 the launch of its adalimumab biosimilar, Hulio, in Spain; the company’s first biosimilar in the country.
Heparin biosimilar to be marketed in Canada
Canadian pharmaceuticals firm Valeo Pharma Inc has been given the rights to market a biosimilar version of low molecular weight heparin (LMWH), which is used to prevent blood clots in a range of conditions.
Trastuzumab biosimilar to be distributed by Mundipharma
Singapore-based Prestige BioPharma’s (Prestige) trastuzumab biosimilar Tuznue (HD201) will be distributed in selected European markets exclusively by UK-based Mundipharma International (Mundipharma) and its independent associated companies. Tuznue is a biosimilar of Roche’s Herceptin (trastuzumab) which is used to treat patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Mylan launches first trastuzumab biosimilar in Australia
Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.
