Significant biosimilar activities this week include:
09 Oct 20, CN: Innovent and Eli Lilly jointly announced China's NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for the treatment of patients with diffuse large b cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia.
10 Oct 20: Celltrion presented positive interim results from Ph I trials of CT-P13 of subcutaneous Remsima® (biosimilar infliximab) in IBD at the UEG Week Virtual 2020. The results indicated that subcutaneous infliximab may be associated with better clinical outcomes compared to intravenous infliximab.
12 Oct, 20, US: two amicus briefs were filed in the 7th Circuit Court of Appeals in support of the plaintiffs in the Humira® (adalimumab) antitrust legislation UFCW Local 1500 Welfare Fund v AbbVie, Inc. The US Public Interest Research Group jointly filed its brief with Consumer Action, arguing that AbbVie's conduct was anticompetitive, and that the District Court's decision should be overturned. In its brief, the Open Markets Institute argued that the District Court should have evaluated AbbVie's patent applications and lawsuits as a series of sham filings.
12 Oct 20, US: Alexion announced it has received FDA approval for a new formulation of Ultomiris® (ravulizumab). The new 100mg/mL formulation reduces the average infusion time by approximately 60%.
13 Oct, 20, BR: Korea Biomedical Review reported Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Government.