FDA Accepts Bio-Thera's BLA for Bevacizumab Biosimilar

The FDA has accepted a biologics license application (BLA) for the review of BAT1706, a proposed biosimilar to bevacizumab, referencing Avastin. If approved, the Bio-Thera Solutions biosimilar candidate would become the third bevacizumab biosimilar on the US market. The others are Mvasi and Zirabev.

In the United States, Mvasi (Amgen) was launched in July 2019 and Zirabev (Pfizer) in January 2020. By June, 2020, these biosimilars had achieved a 40% share of the US market for bevacizumab, according to Amgen.

Zirabev and Mvasi were launched at average sales prices (ASPs) 19% and 12% below the ASP of Avastin, respectively. By the end of the second quarter of 2020, they had contributed to a 2% decline in the ASP of Avastin.

Bio-Thera is a Guangzhou, China-based company with offices in Beijing and Cambridge, Massachusetts. The FDA has established a November 27, 2021, decision date for the application.

Bio-Thera is seeking approval for use of BAT1706 in the treatment of metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, first-line treatment of nonsquamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and persistent, recurrent, or metastatic cervical cancer.

The company said it has also filed for regulatory approval in China and the European Union, thereby “demonstrating Bio-Thera’s commitment to developing BAT1706 to global standards so that BAT1706 can be made available to the global cancer patient community.”

Bio-Thera said the BLA submission is based on positive data from preclinical comparison studies, pharmacokinetic studies, and an international, multicenter, phase 3 clinical comparison study. These provided evidence that BAT1706 is highly similar to the reference product in terms of clinical efficacy, safety, and immunogenicity, the company said.

The company has commercialized 1 biosimilar so far, to adalimumab, a rheumatologic and gastrointestinal therapy. The product is Qletli, which references AbbVie’s Humira and is marketed in China. The company is also developing biosimilar versions of tocilizumab, golimumab, ustekinumab, and secukinumab, which are all immunosuppressants and indicated for such conditions as arthritis and plaque psoriasis. The company is also developing a mepolizumab biosimilar, an anti-inflamatory for the treatment of asthma, eosinophilic granulomatosis, and hyperosinophilic syndrome.

In December 2020, Bio-Thera announced it had formed a partnership with Brazil-based Biomm for the commercialization of BAT1706 in Brazil. Biomm will file the regulatory application.