Biosimilars
Qilu starts phase III trial for denosumab copy biological
Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).
Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis
Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].
Biologicals and biosimilar use in Asian patients with IBD
The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].
Adalimumab 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 the approval of adalimumab copy biological UBP1211.
Oncology pharmacists issue position statement on biosimilars
On 4 October 2019, the International Society of Oncology Pharmacy Practitioners (ISOPP) issued their global position on the use of biosimilars in cancer treatment and supportive care.
Phase I trials started for aflibercept and ustekinumab biosimilars
Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.
South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.
Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab
A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.
FDA approves pegfilgrastim biosimilar Ziextenzo
Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).
Clinical data requirements for biosimilars in the EU: immunogenicity comparability
The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.
Tanvex BioPharma’s filgrastim biosimilar comes under fire
Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.
