Biocon Biologics Ltd is looking to expand its insulin portfolio in the US market as global innovators focus on more lucrative GLP-1 obesity therapies.
The biosimilar arm of Biocon Ltd, which has a 15-17% share of the US insulin market, recently announced that it will supply insulin glargine pens to US non-profit Civica, which will offer them commercially at a low cost in California.
The plan is to expand this model to all US states, said Shreehas Tambe, CEO and managing director of the firm, in an interview with Mint.
Read also | Why India is making preventive healthcare a must for future doctors
Under the multi-year exclusive distributor agreement, announced on October 16, Biocon Biologics will manufacture and supply insulin glargine pens to Civica, which will commercialize them based on the Bengaluru-based firm’s existing marketing approval through a private label arrangement.
Civica will distribute, promote and sell the drug in California under the brand name CalRx for a maximum price of $11 per pen.
“This is a first-of-its-kind deal where an Indian manufacturer, manufacturing from Malaysia, will label a product as CalRx, which is for the California government. It will be available through an exclusive partnership for several years, so it’s almost a guaranteed deal in a major US state like California,” Tambe said.
The state accounts for approximately 12-15% of total US insulin consumption, he added. “…this is just one state. If 50 states were to follow, you’re looking at a very, very significant opportunity.”
Read also | As food delivery giants use health wave to fight slumps, they justify valuations
Biocon Biologics will commercialize insulin glargine in the US starting in 2021 under the brand name Semglee and will also continue to sell it.
Semglee is the first and only insulin glargine replaceable biosimilar pen approved in the US. Interchangeable status means that the biosimilar can be substituted for the reference medicine (in this case, Lantus from Sanofi) without the need for consultation with the prescribing physician.
His second offer
In July, the company also received US Food and Drug Administration approval for rapid-acting insulin aspart (Kirsty), marking another first and only interchangeable option to Novo Nordisk’s Novolog. In cooperation with Civica, he plans to manufacture Kirsty in the USA.
The total addressable opportunity for both glargine and aspart was about $1 billion each, Tambe said.
The US is Biocon Biologics’ largest market overall. While Tambe didn’t specify how much the company expects its share to grow, with Kirsty and CalRx in the mix, he said it would add to their existing sales and “huge opportunity.”
A key factor in the company’s favor is the lack of competition. It is already the fourth largest producer of insulin in the world. There is no other biosimilar interchangeable insulin analog on the market, Tambe added.
Top innovators are also shifting their focus to more lucrative anti-obesity GLP-1 therapies. Novo Nordisk announced earlier this year that it would be phasing out its human insulin pens globally.
Read also | Ozempic manufacturer Novo Nordisk will lay off up to 150 people in India
“There’s obviously going to be a gap in terms of what’s available, and that presents a huge opportunity for Biocon to really come in and use that space to serve patients,” he said.
In addition, biosimilars and generics have also been exempted from the recent 100% import tariffs announced by the Donald Trump administration.
In the first quarter of 2025-26, Biocon Biologics’ sales rose 18% year-on-year to ₹2,458 million crowns and Ebitda (earnings before interest, taxes, depreciation and amortization) increased by 36% on a like-for-like basis on ₹645 crore in the quarter ended June 30. Its Ebitda margin rose to 26%. The US accounted for 40% of its total revenue.
