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“Most of our biosimilar entities are focused on oncology and inflammation. We have a couple of oncology molecules, of which one would enter the clinical trial phase soon. There are other two molecules in pre-clinical stages and the rest are in development stages. For one molecule, our trials will be over in the next few months and we hope to receive regulatory approvals in the next six months,” said Cyrus Karkaria, president - biotechnology, Lupin, without giving further details.
Last year, Lupin had consolidated and expanded its US portfolio, which now fetches more than a third of its revenues. In the bio-pharmaceuticals segment, which does not contribute much to the business right now, it is hoping to gain traction in the coming years, said Karkaria.
“Biotech is a critical segment but it hasn’t developed for us as yet. The challenge is that no guidelines have been initiated in the US markets and in India too there’s no single policy on the subject. So there is a lot of ambiguity regarding biologics. In India’s case, though the regulations do not lack, they need to be properly interpreted,” he said.
Going forward, the biosimilar division is expected contribute about 5 to 7 per cent of the total business.
Meanwhile, the new manufacturing facility, which would come up near the existing one in Pune, will be ready in the next two to three years. “Once we gain momentum in the products pipeline, we hope to build a major plant in Pune. We are capital intensive and our investments are calibrated,” he said.




















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