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Lupin Ltd is planning to file pegfilgrastim biosimilar drug in Q4FY20 in US and clinical trial of the drug are in advance stage, Dr Cyrus Karkaria, president, Biotech Division said.
The company has built a biotech facility in Pune consisting of both mammalian as well as microbial manufacturing setup in place. The company's vision in biotech segment is to develop and commercialize biosimilar globally and evolve into making new biological entities. The company is also eyeing its presence in regulated and self-regulated markets by 2020. Biosimilars involves more complexity compared to chemical drugs.
The total biosimilar market size is US$ 33 billion and the opportunity of biosimilars for global market is evolving, as biosimilars have seen good adoption in Europe and US.
Cyrus Karkaria said, “We decided that we are going to go from the bottom up because that’s the only way, you can get things integrated within the company. And I must say we have been fairly successful as of now."
"We are No. 3 in Etanercept product in Japan and Europe, US also we will be no. 3," Karkaria said.
Recently, the company has recently executed 528-patient biosimilar trial for Etanercept in Europe, Japan and India.
The company has filed 50 patents and as of 7 filed as complete specifications, 12 as national phase and 31 filed as provisional application. The company currently has 320 employees in the company's biotech division.
Recently, Lupin and YL Biologics received approval to manufacture and sell YLB113, a biosimilar etanercept product, in Japan. The product will be Lupin’s first biosimilar to come to the Japanese market.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID space and holds global leadership position in the anti-TB segment.
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