Over the past two years, Biocon has seen several global successes. Its biosimilar insulin glargine was launched in Japan in July 2016, it won a massive contract for the rh-insulin biosimilar from Malaysia’s health ministry in January 2017 (the country’s first locally manufactured biosimilar), and its breast and gastric cancer drug won approvals in the US and Brazil in December. These have pushed up the Biocon stock to record levels, with the shares rising 83% in 2016 and 70% last year. The scrip, which was valued at about Rs 173 at the beginning of 2016, closed at Rs 605 on the BSE on Monday. In an interaction with TOI, Biocon founder, chairperson & MD Kiran Mazumdar-Shaw said biosimilars would start contributing to revenue from the next fiscal year and the company would touch $1 billion in revenue in the same year, the company’s 40th year of operation. “Getting to the next billion will be easier,” Mazumdar-Shaw said. Excerpts from the interview:
How difficult is making a biosimilar compared to a chemical molecule?
Generic molecules are chemically synthesised and are easy to make a copy of than biologically produced molecules as the latter is a protein which is complex and is a large molecule. To put it in perspective, if a small molecule (generics) is a pin head, then protein is like a big symbol. It is made more complex by the fact that it is a collection of peptides. A body produces proteins that perform many functions, they shape themselves in certain ways, and we don’t know how the body does it, so mimicking these proteins is tough. A protein produced externally in different conditions will never be the same as the source. It will only be similar. You need high understanding of biology and biological science to understand this technology.
Why have most Indian pharma companies shied away from making biosimilars?
Most Indian pharma is about chemical synthesis. They have mastered that but most have stayed away from investing in biologics because they are complex and expensive. For biologics, you need to set up a separate infrastructure, spend huge on research and development (R&D), use different kinds of equipments to check the integrity of proteins, do three-dimensional analysis, among other things.
Over the first 20 years of my starting Biocon, we became very good at building enzymes, and enzymes are nothing but proteins. With enzymes, you don’t have to be so meticulous as you are using them as an industrial additive, an organic catalyst to break starch into glucose or fats into fatty acid. Then we took on the challenge of biopharmaceuticals. But human proteins are more complex, as they belong to the immune system, metabolic system and endocrine system. We have a very interesting group of scientists – immunologists, biologists, geneticists, protein chemists, bioinformaticians – who can together look at the protein and address the integrity of the protein to see how close it is to the original human protein. When we make recombinant human insulin, it has to completely mimic the insulin produced in your body. Similarly when we make an antibody. India has excellent biologists.
How much more is the investment needed for making biosimilars compared to generics?
It is much more expensive as it has to be made in sterile conditions. While a generic can be done in six months, a biosimilar takes five years and yet there is no guarantee that it will be approved by the regulators around the globe. If it takes $1 million to develop a generic molecule, then a biosimilar costs anywhere between $100 million and $200 million. A pharma company would rather do 100 small molecules rather than one biosimilar. That is why an aspirin can cost 10 paise while a biosimilar would cost about Rs 10,000.
Are biologics the answer to cancer?
Globally, there is a trend among the big pharma companies to move to biologics from small molecules to cure diseases that cannot be treated with chemicals. About 75% of their pipeline now consists of biologics. A large number of cancers are curable through immunotherapy which attacks the specific cells that have turned malignant (immunotherapy or biologic therapy is a type of cancer treatment that boosts the body’s natural defences to fight the cancer).
In a cell cycle, a cell is born, it grows, and it dies. If the cell death does not take place, it keeps on duplicating, and it becomes a tumour. Your body is unable to recognize this as a strange phenomenon because the cell fools your body into believing it’s part of the natural process by creating certain hormones or in other ways. When you discover the tumour, you have to kill it. With chemotherapy, you bombard the cells with a poison and kill it. The trouble is you don’t completely kill it because somewhere that cell is growing and it will again come back. And you are damaging healthy tissue too.
In immunotherapy, you aid the body into killing the cell. But I have to first understand why the tumour is fooling the body. Each cancer is specific. Once we understand the specificity and develop an antibody, it parks itself on the tumour and suppresses the messaging to the body that what’s happening is normal. Then the T cells, the body’s fighting mechanism, attacks the cell and kills it. This is a permanent cure. Our immune system is the most amazing in the world, so complex and so marvellous and so miraculous. Our breast cancer drug, which was recently approved by the US FDA, will only attack the points in the body required.
Are you bringing down the cost of such treatments compared to that in the West?
Yes. The cost of using the treatment for one year is about $100,000 per patient while in India we have been able to bring it down to between $5,000 and $10,000. It is still expensive considering it translates to Rs 3-6 lakh per year. We are cross subsidising by selling at higher prices in other markets.
What are the biosimilars that Biocon has in its pipeline?
We have about 6-7 molecules. Pegfilgrastim, a drug used to bolster white blood cells in cancer patients, has been filed for approval in the EU and US and other markets. Bevacizumab, another drug for cancer, has been launched in India and is in its phase-III trials globally. Insulin glargine (for diabetes treatment) has been recommended for approval by an expert committee of the European Medicines Agency. As for our oral insulin, we are in a pivotal phase-III trial in India, which means if we can show its effectiveness, it will be approved. The challenge (with oral) is proteins are broken down into enzymes once swallowed. So we have to prevent that from happening, and ensure it gets into the bloodstream.