Pearce IP BioBlast: w/e 25 December 2020
Significant biosimilar activities this week include:
21 Dec 20: Celltrion announced Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire in the EU in September 2023 and in the US in July 2024.
21 Dec 20, BR: Bio-Thera Solutions announced it has reached a licensing agreement with Biomm SA for BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera has filed license applications for BAT1706 in the US, EU and China.
23 Dec 20: Roche announced results for its investigational bispecific antibody faricimab in patients with diabetic macular edema. Roche announced that the candidate was generally well-tolerated with no new safety signals identified. This product is being developed as a replacement for Lucentis® (ranibizumab), which lost patent protection in the US this year.
24 Dec 20, US: the Centre for Biosimilars interviewed Christophe Bourdon, senior VP and general manager of US Oncology at Amgen following FDA approval of Riabni® (biosimilar rituximab). Bourdon stated that Riabni® will be made available through speciality and wholesale distribution, and that Amgen is confident it will be able to support a quick uptake of this biosimilar.
25 Dec 20, US: Biocon announced that it has been informed by the FDA of a deferred action on the BLA for its proposed bevacizumab biosimilar. This deferral was attributed to COVID-19, as the FDA was unable to conduct the required inspection of the manufacturing facility. Biocon is now awaiting dates for the inspection to occur.