Lupin rises on receiving USFDA nod for Pegfilgrastim Biosimilar application

Lupin Ltd, a global pharmaceutical company, announced today that it has received the approval from United States Food & Drug Administration (USFDA) for its biologics license application (BLA) of its biosimilar to Neulasta (pegfilgrastim). The BLA submission has been supported by similarity data derived from analytical, pharmacokinetic, pharmacodynamic & immunogenicity studies.  

Pegfilgrastim can be used to stimulate the production of white blood cells (neutrophils). It can be used to stimulate the bone marrow to produce more neutrophils to fight infection in patients, who are undergoing chemotherapy. As per the study of IQVIA, Pegfilgrastim has estimated annual sales of USD 3.66 billion in the US.   

A company official commented on this development by saying that Pegfilgrastim filing is its (the company’s) first biosimilar filing in the US and is a milestone in Lupin's research & innovation journey. The company has a sharp focus on delivering unique and affordable solutions to alleviate the disease burden. Biosimilars form a key part of the company's growth strategy and it is proud of the world-class achievements of the group.  

At 3.31 pm today, the share price of Lupin Ltd was trading at Rs 1,241.05, which was an increase of 2.68 per cent over its previous day’s closing price of Rs 1,208.65 on BSE.