Bio-Thera Reaches Licensing Agreement With Cipla for Bevacizumab Biosimilar

January 16, 2019
Samantha DiGrande

Bio-Thera announced yesterday that it has partnered with Cipla Limited in a licensing agreement for its potential bevacizumab biosimilar, BAT1706, referenced on Avastin.

Bio-Thera announced yesterday that it has partnered with Cipla Limited in a licensing agreement for its potential bevacizumab biosimilar, BAT1706, referenced on Avastin.

Under the agreement, Cipla will have exclusive rights to distribute and market the drug in certain emerging markets. BAT-1706 is currently being investigated in a global phase 3 study in patients with previously untreated advanced nonsquamous non—small cell lung cancer. The reference product, Avastin, is currently approved in 6 indications ranging from metastatic colorectal cancer and recurrent glioblastoma, to non-squamous non-small cell lung cancer.

“Bio-Thera is pleased to partner with Cipla to commercialize our lead biosimilar program in select emerging markets. This partnership is an important first step towards making BAT1706, our bevacizumab biosimilar product, availability [sic] globally to help increase patient access to this important cancer therapeutic at affordable prices,” Shengfeng Li, MD, chief executive officer (CEO) of Bio-Thera, said in a statement.

Additionally, through the agreement, Bio-Thera will be responsible for development, product registration with various regulatory agencies, and commercial supply of BAT1706 out of its manufacturing facilities located in Guangzhou, China. Conversely, Cipla will be responsible for the sales and marketing of the product.

“This agreement is in keeping with Cipla’s stated intention to build a strong pipeline of biosimilars through partnerships. We are committed to working towards ensuring patients receive access to life-saving drugs. Through this partnership, Cipla will leverage its strengths in marketing to take this key oncology biosimilar to patients in need,” commented Umang Vohra, MD, global CEO of Cipla.

Bio-Thera also has 2 other potential biosimilars in development: BAT1406, a proposed adalimumab biosimilar, was accepted for regulatory review in October 2018 by the National Medical Products Administration; and BAT1806, a tocilizumab biosimilar that is currently being investigated in late stage clinical trials.

Bio-Thera intends to file BAT1706 for regulatory approval with the China National Medical Products Administration, the European Medicines Agency, and the FDA in 2020.

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