Biocon Gets A Shot In The Arm With FDA Approval For Insulin Glargine

A top executive of biopharmaceutical major Biocon, which has received the US Food and Drug Administration (FDA) approval for the biosimilar insulin glargine, says the drug will be a major contributor to the company’s revenue target of $1 billion through its biologics division by FY22. The drug was co-developed with Mylan.

“The US market represents a great opportunity given that there is only one biosimilar glargine currently available. Glargine is a $2.2 billion market and we believe this product will be an important contributor to our growth in fiscal year FY21 and beyond,” said Christiane Hamacher, CEO & Managing Director, Biocon Biologics. Hamacher said the insulin will be made available to patients in the US soon.

The FDA has given the nod to the insulin in the vial and pre-filled pen format to control high blood sugar in both type-1 and type-2 diabetes patients.

Glargine is the third Biocon-Mylan biosimilar to be approved in the US market after fulphila and trastuzumab, both used for treating cancer. “These three molecules in the US are the biggest component for our $1 billion target that we want to reach by the end of FY22,” said Hamcher.

Apart from these, the company’s biologics licence application for bevacizumab is currently under review with the USFDA and it says it is on track with the development of insulin aspart for global markets.

“As an organisation committed to making insulin-based therapy increasingly accessible for people with diabetes globally, this approval (for insulin glargine) will enable us serve the needs of patients in the US. The approval is also an endorsement of our science, scale and expertise to develop high quality, more affordable insulins and shift the access paradigm in favour of patients, taking us closer to realizing our aspiration of reaching ‘one-in-five’ insulin dependent people with diabetes worldwide,” said Kiran Mazumdar Shaw, Chairperson, Biocon.

The company’s biosimilar segment had reported a de-growth of 21 per cent during the fourth quarter of FY20 because of Covid-19 impact after reporting three consecutive quarters of robust performance. However, Biocon expects normalisation of growth from the segment by the second quarter of FY21.

Biocon has also committed to provide affordable insulin at Rs 7 per day to lower and middle income countries as compared to Rs 350 per day currently. “We are engaging with several governments to explore ways to disintermediate the supply of insulin and ensure that insulin pricing is not a constraint to the well-being of individuals and of communities,” said Hamacher.

Biocon Biologics currently has a product pipeline of 28 molecules, of which it partners with Mylan for 11 of them. Overall, the company is targeting to have at least eight biosimilars being sold in developed markets by the end of FY22 addressing a market opportunity of $35 billion. Biocon Biologics is seeking to continue to deliver at least three additional molecules between FY23 and FY25 and after which it is looking to launch two molecules per year.