Biosimilars/News
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.
Samsung Bioepis starts phase III trial for eculizumab copy biological
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).
Korean firms to launch biosimilars in Japan despite trade tensions
Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second half of 2019.
FDA approves adalimumab biosimilar Hadlima
Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5).
EMA accepts first application for Chinese-made biosimilar HLX02
China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).
Rituximab copy biological accepted for review in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.
FDA approves rituximab biosimilar Ruxience
US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar (PF 05280586).
