Lupin Gets US FDA Approval for Its First Biosimilar Pegfilgrastim

Lupin has received approval from the US FDA for Armlupeg (pegfilgrastim-unne), its first biosimilar drug in the US market. The medicine helps reduce infection risks in cancer patients undergoing chemotherapy or exposed to high radiation doses. This approval strengthens Lupin’s presence in the world’s largest pharmaceutical market.

About the Drug and Its Manufacturing

Armlupeg is a biosimilar version of Amgen’s well-known drug Neulasta. It will be manufactured at Lupin’s biotech facility in Pune, which recently cleared a US FDA inspection. The product comes as a 6 mg prefilled syringe for injection and is used to prevent febrile neutropenia, a condition where cancer patients develop fever and signs of infection due to low white blood cell count.

Market Opportunity in the US

Pegfilgrastim products recorded around $1.29 billion in US sales over the 12 months ending September 2025, according to IQVIA. Entering this market gives Lupin strong potential for revenue growth and a boost to its biosimilar strategy.

Leadership Comments

Lupin CEO Vinita Gupta called this approval a major milestone, stating that it will help the company expand its biosimilar portfolio in the US. Managing Director Nilesh Gupta highlighted that Lupin’s end-to-end biologics capabilities, spanning cell-line development to global regulatory approvals, provide a strong advantage in biosimilar manufacturing and distribution.

About Lupin

Based in Mumbai, Lupin operates in more than 100 countries. Its product portfolio includes branded generics, complex generics, biotechnology products, and APIs. The company has 15 manufacturing facilities, seven R&D centres, and a global team of over 22,000 employees.

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Lupin Share Price Movement

Lupin share price (NSE: LUPIN) is trading at ₹2,081.20, down ₹1.00 (0.05%) today. The stock opened at ₹2,094.90 and moved between a high of ₹2,107.40 and a low of ₹2,062.40. The company has a market capitalisation of ₹95,050 crore, a P/E ratio of 33.49, and a dividend yield of 0.58%. Over the past year, Lupin’s share price has touched a 52-week high of ₹2,402.90 and a 52-week low of ₹1,795.20.

Conclusion

Lupin’s US FDA approval for Armlupeg marks a significant step in its biosimilar journey. This milestone not only helps the company strengthen its position in the US market but also sets the stage for launching more biosimilars globally in the coming years.

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