Biopharma Shakti shows India focusing on being biopharma hub: Biocon's Shaw

After cutting debt and raising $1 billion, Biocon sharpens its biosimilars and GLP-1 play, betting on scale, regulatory reform and AI to power the next growth phase

Fresh from a reduction in debt and a capital raise of $1 billion, Biocon Ltd is sharpening its focus on biosimilars, GLP-1s (glucagon-like peptide-1s), and manufacturing on a global scale. In a video interaction with Sohini Das, Biocon Group Chairperson Kiran Mazumdar-Shaw says how lower borrowing costs will lift profitability, and why regulatory reform and adopting artificial intelligence (AI) are critical for India to be a biopharma hub. Edited excerpts.

 

After substantially retiring debt, has the cost of borrowing come down? 

We raised close to $1 billion through two qualified institutional placements in eight months. The ₹300 crore annual savings will directly add to the bottom line from FY27.

 

Can you throw some colour on the integration of Biocon with Biocon Biologics, which is underway? 

The integration of Biocon Biologics as a wholly owned subsidiary of Biocon is on track. There are overlaps, which will be optimised. Assets in manufacturing are fungible across these segments, providing flexibility and agility. At the same time, there are strong complementary portfolio fits, particularly between GLP-1s and insulins. 

There is also an opportunity to leverage recombinant DNA peptides for GLP-1s, where Biocon Biologics has deep expertise. As Biocon integrates further, there will be optimisation in manufacturing lines and the field force.

 

What is your take on the Biopharma Shakti project, announced in this year’s Budget? 

The announcement shows India is focusing on being a biopharma hub. The ₹10,000 crore allocation is a good first step. It signals intent. The discussion now should be how to leverage Biopharma Shakti to help companies invest more in biosimilar development. 

Every company has to think about investing in manufacturing on a global scale. South Korea has done this, and Biocon is probably the only Indian company that can match the Korean scale in some way. The government needs to support it because this is gestational investment and it does not pay back immediately. 

China has done well over the past few decades, developing novel biosimilars and out-licensing molecules. This has happened because China has fast-track regulatory pathways for novel products and allows a rapid movement of molecules into the clinic. Our ecosystem needs to study that model. The Indian government has made amendments to rules on drugs and clinical trials, aimed at easing clinical trial timelines, particularly for biosimilars. 

Regulators globally are willing to waive clinical trials in favour of robust “chemistry, manufacturing, and control” (CMC), and that is what India should emulate. There is enormous global data on semaglutide. Clinical trials only make the product more expensive.

 

Should waivers on animal trials for biosimilars be encouraged? 

Going by academic work, animal studies are not required for biosimilars. Eliminating them reduces cost and time, and aligns us with global practices. We should stop asking for animal trials. CMC is what matters.

 

What are the concerns around GLP-1 approval in Canada? 

The GLP-1 opportunity in Canada is unclear because approvals have not yet come through -- not even for older molecules. Files approved in Europe and the United States are still under review in Canada. However, our integrated model gives us a competitive advantage over companies sourcing active pharma ingredients, cartridges, and devices from different parts of the world.

 

What is the outlook for generics, which have grown in double digits in Q3? 

Biosimilars remain our primary growth lever. Generics have performed well but are not a large long-term opportunity. We are focused on the Semaglutide opportunities in Canada and emerging markets.

 

Is the funding winter on biotech easing? 

It is easing. Funding conditions in the US are improving, particularly for smaller biotech companies. Capacity utilisation will take time, but visibility is improving.

 

Has the rush to launch generic GLP-1 led to a rise in peptide production in India? 

China dominates peptide manufacturing due to advantages in scale and cost, especially because amino acids are sourced from there. However, in the long term, peptides should move toward recombinant DNA processes, which are better for patients and scalability. Once regulators accept comparability between synthetic and recombinant products, approvals can happen without additional clinical trials.

 

How is Biocon using AI for research, manufacturing and other processes? 

AI is most impactful for novel molecules. It can help select trial sites globally and identify patient cohorts faster. It can help in rapidly identifying eligible patients and optimising global trial enrolment. We use AI across manufacturing, regulatory, quality, and research & development.