He said, “There is very little outstanding information that the regulator wants from us, and we will give them whatever they ask for.”
He added that if the approval process progresses smoothly, the launch could happen soon. He said, “If everything goes well, May should be a timeline from which we think will happen.”Also Read | Biocon Biologics expects FY27 growth from new approvals, weight loss drug pipeline
Prasad clarified that there are no pending site inspections and that the process currently involves submitting additional information requested by the regulator.
On market potential, Prasad said Canada could offer a strong initial opportunity if the company enters the market ahead of competitors.
He said the company expects a short window with limited competition, after which pricing pressure could emerge, similar to other generic markets. He added that India will be a high-volume market but will see strong competition from multiple players launching similar products.
Prasad said the company plans to launch semaglutide in markets where patents allow entry and where regulatory approvals are secured. He said multiple registration submissions have already been made across markets, and launches will follow once approvals are received.
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On India’s business strategy, Prasad said partnerships with global innovators remain an important growth lever.
He said, “We have started working with innovators around the world… and we are bringing access to products, which patients otherwise would not have access to through these partnerships.”
He added that the company aims to deliver double-digit growth at the overall company level, though it does not provide formal growth guidance.
On the US market, Prasad said pricing pressure continues due to intense competition and a higher number of generic filings. However, he said niche opportunities and limited-competition launches still exist.
He added that some biosimilars in the company pipeline could become meaningful from FY27–FY28 onwards, including potential launches such as rituximab.
On acquisitions, Prasad said the company is focused on assets with stable margins and long product lifecycle, especially in branded generics in India and emerging markets. He added that the company is also exploring opportunities in consumer health globally.
The company, which has a current market capitalisation of ₹1,06,952.88 crore, has seen its shares gain more than 7% over the last year.
For the full interview, watch the accompanying video
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