GUANGZHOU, China--(BUSINESS WIRE)--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.
