(MENAFN- Live Mint) Biocon Biologics Ltd is aiming to expand its insulin portfolio in the US market, as global innovators focus on more lucrative anti-obesity GLP-1 therapies.

Biocon Ltd's biosimilar arm, which holds a 15–17% share in the US insulin market, recently announced it will supply insulin glargine pens to US-based non-profit Civica, which will commercialize them at low cost in California.

The idea is to expand this model across all US states, Shreehas Tambe, the firm's chief executive and managing director, told Mint in an interview.

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Under a multi-year exclusive distributorship agreement announced on 16 October, Biocon Biologics will manufacture and supply insulin glargine pens to Civica, which will commercialize them under the Bengaluru-based firm's existing marketing approval through a private-label arrangement.

Civica will distribute, promote, and sell the medicine in California under the CalRx brand, priced at a maximum of $11 per pen.

“This is a first-of-its-kind deal where an Indian manufacturer, manufacturing out of Malaysia, will label the product as CalRx, which is for the Government of California. It will be made available through an exclusive partnership for multiple years, so it's almost an assured business in a large US state like California,” Tambe said.

The state accounts for approximately 12-15% of the total insulin consumption in the US, he added.“...this is just one state. If 50 states were to follow, you're looking at a very, very sizable opportunity here.”

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Biocon Biologics has been commercializing insulin glargine in the US since 2021, under the brand name Semglee, and will continue to market it as well.

Semglee is the first and only interchangeable biosimilar insulin glargine pen approved in the US. An interchangeable status means a biosimilar may be substituted for its reference drug (in this case, Lantus by Sanofi) without requiring consultation with the prescriber.

Its second offering

In July, the firm also received US Food and Drug Administration approval for rapid-acting insulin aspart (Kirsty), marking another first and the only interchangeable option to Novo Nordisk 's Novolog. It plans to manufacture Kirsty in the US in partnership with Civica.

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 did not specify how much the company expects its share to grow, with Kirsty and CalRx in the mix, he said these would be accretive to their existing sales and a“tremendous opportunity”.

A key tailwind in the company's favour is the lack of competition. It is already the world's fourth-largest insulin maker. There is no other biosimilar interchangeable insulin analogue in the market, Tambe added.

Top innovators are also shifting focus to the more lucrative anti-obesity GLP-1 therapies. Novo Nordisk announced earlier this year that it would phase out its human insulin pens globally.

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“There is clearly going to be a gap in terms of what is available, and that offers a tremendous opportunity for Biocon to actually come in and take that space to serve patients,” he said.

Moreover, 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' revenue grew 18% year-on-year to ₹2,458 crore, and Ebitda (earnings before interest, taxes, depreciation, and amortization) rose 36% on a like-for-like basis to ₹645 crore in the quarter ended 30 June. Its Ebitda margin expanded to 26%. The US accounted for 40% of its total revenue.

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