‘Nod for Trastuzumab will open lot of markets’

The US Food and Drug Administration gave its approval for Biocon’s biosimilar — a copy of an innovator biologic drug — for anti cancer drug Trastuzumab. Biocon has become the first Indian company and also the first ahead of three global rivals who got the regulators nod for this biosimilar in the highlyregulated market. This also throws up opportunities for the Bengaluru-based company to tap other global markets with the drug before its launch by its partner Mylan in the US. “This is seven years of research, huge investments in research and development,” KIRAN MAZUMDAR-SHAW, chairperson and managing director of Biocon, told Raghu Krishnan in a telephonic interview. Edited excerpts:

The US Food and Drug Administration (FDA) for Trastuzumab is a milestone for Biocon?

This is not just for Biocon, but a milestone for the country. It is seven years of research and development huge investments and there were no guarantees. We are the first to be approved by the US FDA for Trastuzumab and there are three people waiting in the queue. These are big companies — Pfizer, Amgen and Merck.

It means our credibility has been established that we are a company that has the high-end capability to seriously look at the global market with our biosimilars. It means that all the scepticism around Biocon being an Indian company and not been able to play in big league is being debunked. It also strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world. It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients

We saw the European Medical Agency (EMA) accepting application for Trastuzumab and Pegfilgrastim?

The Europeans have basically said that we will review it again and it will be part of inspection. It is likely that everything will be much easier now with the US FDA nod. We still have to go back with corrective and preventive actions (CAPA) for Pegfilgrastim. We completed the CAPA in time for Trastuzumab. We have got a nice pipeline of products: Bevacizumab is in global phase-III trials and Glargine is under review both in the US FDA and EMA. We are doing well.

When will you take Trastuzumab to the US market?

The marketing will be done by (partner) Mylan (Mylan has exclusive commercial rights for the US but the two companies will share profit from sales). They have an agreement with Roche (the innovator of the drug), they have a certain patent understanding. They will take it to the market as soon as they can.

Would we see this having an impact in revenue from next year?

It will see some impact from next year. First and foremost , the US FDA approvals opens up many markets that were previously not open for us. The rest of the market has a $2-billion opportunity for Trastuzumab. Many markets have been kind of forced into closing the doors by the innovator themselves on various grounds like quality is suspect or you are putting patients at risk.

In India, itself they are litigating, why are you approving for them. We are fighting a case with Roche in India, which has been debunked. All this will not hold water for them now. The moment the US FDA gives an approval, basically, the decks are clear.

The firm is going to see some good revenues coming next year. We might have an entry opportunity into the US and Europe next year, but the real numbers will come around the following fiscal.

WE ARE THE FIRST TO BE APPROVED BY US FDA FOR TRASTUZUMAB AND THERE ARE THREE PEOPLE WAITING IN THE QUEUE