Bio-Thera Solutions Ltd ("Bio-Thera") announced today that it has reached a licensing agreement with Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets.

BAT-1706 is a mAb biosimilar to Genentech's Avastin® which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer. Bio-Thera's BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) in 2020.

This partnership will leverage Cipla's strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.

"Bio-Thera is pleased to partner with Cipla to commercialize our lead biosimilar program in select emerging markets", said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership is an important first step towards making BAT1706, our bevacizumab biosimilar product, availability globally to help increase patient access to this important cancer therapeutic at affordable prices."

"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." said Umang Vohra, MD & Global CEO of Cipla Limited.

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