What is the theme for the BIO conference to be held in April this year?
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| Lila Feisee |
The theme this year is partner, connect, innovate. We are having a BRIC day wherein on the first day, there would be two parallel tracks with a focus on China and Russia in the morning and India and Brazil in the evening. Our theme for India this year is “Can India be a leader in biotech innovation?” That is the big question and we have half a day dedicated to exploring that. Biotech innovation means cutting edge research and development, coming up with novel products, not generics. So we would discuss if Indian companies can actually be innovators, i.e come up with the first product that someone else can copy. We think that the potential for India to do that exists, because there are institutions, scientists, researchers and the entrepreneurial spirit. The tendency to innovate is there, what is keeping India back, is the policies the Indian government has put into place. This is holding not only western companies but Indian industry back as well. The latter are finding the gaps and trying to fill them in, by doing contract research, but that is not helping them meet their full potential.
Collaboration is a key to fostering innovation. How do you think India has fared in this respect?
On the collaboration front, India has made a lot of effort in trying to develop a strategy for biotech under the leadership of Dr MK Bhan, Past Secretary, Department of Biotechnology (DBT). This included proposals to look at how to translate some of the research that is being done, to find collaborators and then to develop products, essentially the technology transfer part of it. The larger issue is how is that actually managed, is it too bureaucratic, are there too many hurdles. If there are too many requirements, that hinders such collaborations and one cannot go to the next level. There is a need to foster collaborations between foreign universities and Indian universities, Indian companies partnering with each of them or both or even western companies doing that. So the opportunity exists, but the question is how is that facilitated. The concept for building funding institutions is there, but translating the research into products is the missing link and needs to be pondered upon.
Many MNCs have come in the line of fire in the recent past owing to India’s IP laws. Has that made investors wary of the Indian market?
Biotech is a very IP intensive industry. It requires a lot of investment of money, time, human capital and intellectual capital to make biotech products. For a country that wants to build an innovative sector, building IP is important. Not only IP, but strong IP, and not only strong IP but predictable IP. As is evident, one can’t make quick money in biotech, it takes a decade or two decades to get returns on the investment trickling in. This needs to be conveyed to the investors, even as they keep pooling in money. Of course, knowing that once you have the patent, you can enforce it, helps. But with compulsory licenses and patents being revoked, there’s no protection, leading to uncertainty. Its hard enough to invest in biotech in the best possible situation, because one needs to watch and wait and see if your investment bears fruit. Even Indian investors face the same constraints with less capital to boot.
What are your views on the regulatory environment in India?
A significant regulatory process that is transparent, science based and indicates clearly what is needed to comply helps. However, the data that is submitted needs to be protected, data exclusivity should be there. Regulatory process should have two pathways: one for the innovator- biologic to come into the market, which requires a full data package with clinical trials and preclinical and PKPD in a robust manner. However, it shouldn’t be so onerous that you can’t get something approved, at the same time one should have enough information to get the product to the patient safely. A second pathway for biosimilars- because once the biologic is on the market and they are past the time taken to recoup their investment, then there should be an abbreviated pathway for biosimilars, not the same as the biologics, but at the same time not compromising on patient safety. So with those two pathways, you can bring the cost of medicines down, have a thriving biotech sector with both innovators and biosimilars coexisting side by side.
How do you look at the Indian biosimilar guidelines?
The biosimilar guidelines are relatively in line with WHO and EMA, have a combination of both, But how does (a company) demonstrate safety and efficacy and how much data does one need to put in, that is where the debate and discussion lies. The data doesn’t need to be loaded so much that it is similar to the innovator, but at the same time it can’t be so relaxed, so striking the right balance on data in the interest of patient safety is crucial for biosimilars. Both the US and India seem to be in agreement to the fact that it is essential to get biosimilars that are safe to the patient. There need to be clinical trials, but how much that is the moot point. From our perspective, India is moving in the right direction, but the one thing that they can add is data protection, that is not part of the regulatory system as of now.
What are some of the challenges to get biosimilars to the market?
The European Medicine agency (EMA) and Food and Drug Administration (FDA) have separate requirements, so there is no uniformity across both which might be a barrier for Indian companies planning to sell their products in these markets. They would need two sets of data packages to meet both requirements. From an innovators perspective, we’d also want convergence there. In the US, biosimilar law has gone into effect and we have three sets of guidance. In the US, if you can prove interchangeability, the law allows for it. The question is how do you prove that the biosimilar is interchangeable with the actual product. We think that there should be a rigorous assessment of that because the clinical outcome has to be the same for both. India and US are in the same boat since both have just come out with their biosimilar guidelines, companies are yet to see how those guidelines are yet to be implemented.
How would you compare the funding for R&D in the US and India?
We recently got new data saying that investment has gone down in biotech, but its slowly coming up in the US. The problem for a lot of our companies is that their research is in earlier stages, but it is not in that zone where it has attracted the big investors. We call this the valley of death, which is dry with funding, its all about crossing to the other side. What has happened in the US is that there are several different mechanisms- angel investors who focus on specific or niche areas, patient organisations such as Alzheimers foundations, and then the larger companies are also creating other funding sources. As BIO, is that we do a lot of partnering, with countries such as China, who wants to do a lot in R&D including countries in the Middle East who want to fund R&D in the US.
