Will launch 3 biosimilars globally in 2-3 years: Biocon Biologics CEO & MD

Shreehas Tambe, MD & CEO, Biocon Biologics talks about refinancing, upcoming launches, and future roadmap, in a virtual interaction

Biocon Biologics, a subsidiary of Biocon, had refinanced $1.1 billion (Rs 9,300 crore) debt last month. The company’s managing director and chief executive officer Shreehas Tambe spoke to Sanket Koul and Aneeka Chatterjee in a virtual interview on issues ranging from refinancing, launches, and the roadmap. Edited Excerpts:

 

With the successful refinancing of long-term debt of $1.1 billion, how does BBL plan to leverage it?

 

One of the important developments of this quarter is the strategic refinancing of our long-term debt through a $800 million bond issuance and a new syndicated long-term loan facility of $300 million. We had taken on this debt to support the transformational acquisition which moved us from being a Science and Operations led company to becoming a fully integrated global biosimilars organisation, which now has its presence in over 120 countries.

 

That debt needed to be refinanced for greater financial liquidity so that we could re-deploy investments into the business to fuel growth. This refinancing will now help us to focus on growing the business, without worrying about the quarter-by-quarter debt-to-Ebitda ratio or servicing of the debt beyond paying off the interest.

 

Do you have any launches lined up in the coming quarters?

 

If I broaden the horizon to the next two to three years, say, from FY25 through FY28, we are one of the few companies in the industry today, which has five new biosimilars awaiting global launch. 

 

So, those products will drive Biocon Biologics’ growth, not just in the second half, which is a near-term situation, but for the mid and long term. Over the next two to three years, we have five new biosimilars, which will be launched in the US. These include Aspart, Bevacizumab, Aflibercept, Denosumab and Ustekinumab. 

 

Two of them, Aspart and Bevacizumab have already been launched in other geographies. For Aflibercept, we have discussed launching the product in the middle of next year in Canada. 

 

We have an exciting pipeline of near-term opportunities with three global launches (bAflibercept, bDenosumab and bUstekinumab) and five launches (bAspart, bBevacizumab, bAflibercept, bDenosumab and bUstekinumab) in the United States in the next two to three years.

 

With over 50 blockbuster molecules and biologics expected to go off patent, how is Biocon Biologics positioning itself to succeed in the biosimilars market?

 

Between 2022 and 2032, you would see 55 blockbusters, each product having sales of over $1 billion annually, losing exclusivity. Their cumulative peak sales will exceed or would be exceeding $270 billion.

 

So, there is a massive opportunity ahead of us. The therapy areas we are targeting include diabetes, oncology, immunology. We have an interest in ophthalmology as well. Incidentally, the three prime areas that we are focused on also happen to be witnessing the fastest growing healthcare spends globally. 

 

Our focus is on developing therapies for diseases with global prevalence and where public healthcare expenses are the highest. Our strategies are sound, and we are well positioned to capitalise on macroeconomic trends that support making high-quality, affordable biosimilar treatments more accessible to patients globally, potentially delivering billions in annual savings to health systems.

 

Can you elaborate on your localisation plans in Africa, West Asia and Turkiye? 

We are working on how we can bring products closer to patients. It has been our constant endeavour to see how our products can be filled in different markets closer to patients, so that we can reduce logistics costs and improve the ability to bring in more reliability of the supply chain.

 

We have been successful in building manufacturing capacity in some regions, but we will be looking to do that in other regions now that we are a global company with a large commercial presence. In line with our transition to a global company, we will be actively building a global supply chain, an external broad manufacturing network, which is closer to the markets we operate in.

 

What is the timeline on the Bmab 1200 (Yesintek) launch in foreign markets markets after Biocon Biologics’ settlement and licensing agreement with Janssen?

We have previously announced a settlement agreement with Janssen Biotech Inc. and Johnson and Johnson for Yesintek, our biosimilar Ustekinumab, to secure a U.S. market entry date of February 2025, subject to US Food and Drug Administration (USFDA) approval.

 

At this stage, we have not heard back from the USFDA on the facility inspection. The date for Ustekinumab BLA is still some time away. We are looking forward to receiving the approval, which will pave the way for the launch of Yesintek in the US. 

 

In addition to the US market, we have been able to reach an agreement on the launch dates for Europe, Canada, UK, and Japan. Once we have approvals in these markets, we will be looking to launch Yesintek as well.

 

In an interview with Business Standard, you have said that Biocon aims to become among the top three biosimilars companies in the world. Is there a timeline?

 

We are number five in the world today in the biosimilars space. And we are looking to get to number three and then eventually number one. We are not disclosing or discussing any timelines. This is an aspiration for us, as a company headquartered in India with global ambitions. We aspire to be amongst the top three biosimilars companies in the world.