'We recently launched Yesintek in the immunology space.'
Biocon Biologics Ltd (BBL) reported robust growth in 2024-25 (FY25), driven by rising biosimilar market share in the US and emerging markets (EMs).
Its managing director and chief executive officer Shreehas P Tambe, in a video interview with Anjali Singh and Aneeka Chatterjee/Business Standard, outlines the company's product pipeline, insulin strategy, glucagon-like peptide-1 (GLP-1) plans, and efforts to strengthen global presence.
What were the key drivers for BBL's growth in the fourth quarter of FY25?
Achieving 15 per cent year-on-year revenue growth, with nearly four biosimilars generating $200 million in revenue, is a huge feat.
It reflects strong customer confidence in our products and the successful integration of our businesses.
This growth is driven by increasing market share, particularly in the US, where our biosimilars pegfilgrastim (Fulphila) and trastuzumab (Ogivri) now hold over 30 per cent and 26 per cent share, respectively -- double compared to last year.
Beyond the US, we have also performed well in EMs, winning key tenders that have contributed to our overall growth.
BBL has mentioned five new products in the pipeline. Could you share the timeline and India-specific details, including the therapeutic areas these launches will target?
We have five products that will launch in the next 12-18 months.
We recently launched Yesintek in the immunology space -- a biosimilar to the $10 billion drug Stelara -- in both the US and Europe, which we will bring to India as well.
It has already gained traction in the US, and we have 70 per cent coverage from pharmacy benefit management (PBM).
Our second product is insulin aspart, which is expected to become the first interchangeable biosimilar of a rapid-acting insulin analog to be approved by the US Food and Drug Administration (FDA). We expect approval by calendar year 2025.
The third product is Yesafili, a biosimilar to aflibercept used in ophthalmology. We are launching it in Canada this July and have reached a settlement with the originator to launch in the US in the second half of 2026.
Our fourth product is denosumab, branded as Prolia for bone health and Xgeva for oncology.
It has recently received approval from the European Medicines Agency, and we are actively pursuing USFDA approval.
The fifth product is bevacizumab, a biosimilar to Avastin, in the oncology segment.
It has already been launched in Europe and is approved for launch in the US, which we plan to execute shortly.
Tell us about the demand for insulins in key markets. After the Viatris acquisition, have new markets opened up for you?
Mexico and Malaysia continue to be very strong markets for us in insulin, with market shares in excess of 90 per cent and over 60 per cent, respectively.
But beyond these, we've gained market share in other countries as well -- not necessarily because of the Viatris acquisition, as we already had a strong presence in EMs.
What the acquisition really gave us was access to markets we weren't previously in -- primarily the US and parts of Europe.
In the US, our insulin market share has grown from under 5 per cent to nearly 18 per cent, if you include the government business.
As for Europe, while Viatris had a limited sales force in place, we are now strengthening our presence there.
So you will see a step-up in our European insulin business going forward.
In line with the parent company's decision to raise a fund of Rs 4,500 crore, how much of that is expected to be allocated to BBL and for what initiatives?
One of the key objectives is to explore options for retiring some of our structured debt.
We have previously discussed deleveraging our balance sheet, and that remains a strategic focus.
Despite running a robust business with strong earnings before interest, tax, depreciation, and amortisation (Ebitda) performance, the impact of debt is evident when moving from Ebitda to profit after tax -- interest costs reduce our profitability.
The qualified institutional placement is aimed at addressing this gap by helping us deleverage and improve overall financial efficiency.
With semaglutide set to go off patent next year, does BBL have plans to develop or launch its weight loss drug in this segment?
Yes. While many are now exploring GLP-1 development, it is important to note that this is not as straightforward as producing a pill.
Though oral versions are in the works, the current standard is injectable, delivered via a pen device.
Manufacturing such a product demands specialised capabilities, not just in drug substance and drug product (cartridge filling), but also in device technology.
Our insulin infrastructure is highly fungible for GLP-1 production. Unlike others who would need to make investments to build these facilities, we are already fully integrated.
We also have extensive experience in cartridge filling and pen injector devices, which directly benefit patient usability.
Over the years, we have built strong capabilities using these devices.
Feature Presentation: Aslam Hunani/Rediff
© 2025