Tony Hagen is senior managing editor for The Center for Biosimilars®.
Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.
A Guangzhou, China, company that has submitted a bevacizumab biosimilar candidate for regulatory approval in China and Europe is moving ahead with a similar filing in Brazil.
Bio-Thera Solutions has developed BAT1706 and recently completed a phase 3 comparative clinical study demonstrating equivalence to the reference product (Avastin) for efficacy, safety, pharmacokinetics, and immunogenicity in patients with advanced nonsquamous non–small cell lung cancer who also received chemotherapy.
The company now has contracted for Biomm SA to submit the regulatory paperwork for BAT1706 in Brazil and handle the product distribution in that market. “This partnership will leverage Biomm’s strong local presence, sales, and marketing capabilities in Brazil,” Bio-Thera said in a statement that also explained that it would handle the product manufacturing side of the partnership, utilizing its biopharmaceutical plant in Guangzhou.
“This partnership is the first to expand Bio-Thera’s presence into Brazil, an important pharmaceutical market for biosimilars and innovative drugs,” Shengfeng Li, CEO of Bio-Thera, said in the statement.
BAT1706 is intended for the treatment of patients with metastatic colorectal cancer; metastatic or locally recurrent breast cancer; locally advanced, metastatic, or recurrent non–small cell lung cancer; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Heraldo Marchezini, CEO of Biomm, said his company was eager to expand its activities in the oncology biologics space. "Biomm is committed to expanding its portfolio in biotechnology with a long-term vision, especially in oncology where is critical to expand the access to modern treatments.”