Following the U.S. FDA approval for its first biosimilar product last month, Tanvex BioPharma announced today (8th) that it has submitted a Biologics License Application (BLA) for its second biosimilar product, TX05, to the FDA on July 6th.

TX05, developed in-house by Tanvex BioPharma, is a biosimilar to Herceptin, primarily indicated for breast cancer and gastric cancer. The Phase III clinical trial for TX05 completed its primary efficacy endpoint analysis in February 2021, demonstrating equivalence to the reference drug in terms of safety, immunogenicity, and efficacy, with successful unblinding. Tanvex initially submitted the BLA for TX05 in August 2021 and received a Complete Response Letter (CRL) from the FDA in August 2022. Over the past two years, Tanvex has had multiple communications with the FDA and has supplemented the necessary data. After thorough preparation, Tanvex has now resubmitted the BLA for TX05.

According to IQVIA data, Herceptin-related products generated approximately $1.1 billion in sales in the U.S. market over the twelve months ending March 2024.

Tanvex BioPharma’ first biosimilar product, Nypozi, was launched in Canada earlier this year and received U.S. FDA approval at the end of June. With this prior experience of navigating the stringent FDA approval process, Tanvex is confident in securing its second U.S. biosimilar approval for TX05.

Recently, Tanvex also reported its financial results for May, with operating revenue of NT$13 million and a pre-tax net loss of NT$123 million. The net loss after tax was also NT$123 million, resulting in a loss per share of NT$0.75.

Resource (mandarin): 上月獲美上市許可後，泰福-KY再叩關第二張相似藥藥證TX05