Biosimilars
Positive phase Ib results for TYVYT + bevacizumab copy biological IBI305
China-based Innovent Biologics (Innovent) announced on 1 June 2020 positive results for a phase I trial of its candidate bevacizumab copy biological, IBI305, in combination with TYVYT (sintilimab injection) in the treatment of advanced hepatocellular carcinoma, which is the most common form of liver cancer.
Daewon launches teriparatide biosimilar in South Korea
South Korea-based Daewon Pharmaceutical (Daewon) announced that it has launched the teriparatide biosimilar Terrosa.
Clinical equivalence in oncology biosimilar trials
Researchers from the US propose using restricted mean survival time (RMST) rather than the overall response rate (ORR) and progression-free survival (PFS) or overall survival (OS) in clinical trials evaluating the equivalence of biosimilars [1].
Switching from biologicals to biosimilars in Australia
Switching* patients from originator biologicals to biosimilars has been a topic of keen interest in recent years across the globe, as more biosimilars have emerged onto the market. Authors from Shelston Intellectual Property discussed the unique approach that Australia has taken to switching.
Fresenius Kabi’s pegfilgrastim biosimilar accepted for review by EMA and FDA
Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 22 and 27 May 2020 that the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) had been accepted by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.
Use of biosimilar infliximab gives savings for patients
Canadian researchers carried out a cost-utility analysis of switching from reference to biosimilar infliximab compared to maintaining reference infliximab in adult patients with Crohn’s disease (CD). From this analysis they found that using biosimilar infliximab resulted in cost savings for patients [1].
China accepts IND application for denosumab copy biological HLX14
China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 27 May 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had accepted an investigational new drug application (IND) for HLX4, a denosumab copy biological.
ISOPP publishes a whole host of information on biosimilars
The International Society of Oncology Pharmacy Practitioners (ISOPP) has published a whole host of information on biosimilars in a supplementary issue of the Journal of Oncology Pharmacy Practice.
First subjects dosed in Australian phase I study of denosumab biosimilar
Taiwan-based JHL Biotech announced on 18 May 2020 that the first group of subjects has been randomized and dosed in the week of 11 May 2020 in the company’s Australian phase I clinical trial of its candidate denosumab biosimilar (JHL1266) in healthy subjects.
WHO prequalifies first rituximab biosimilar
The World Health Organization (WHO) has prequalified its first rituximab biosimilar as part of its efforts to make life-saving treatments more affordable and available to patients globally.
