In a free wheeling conversation with Viveka Roychowdhury, Dr Dhananjay Patankar, biopharma consultant, explains why Indian biopharma companies should feel more confident to take the higher investment risks required to tap the US biopharma market, given the successes in Europe, the overall talent base and understanding within the Indian industry. He also emphasises why more engagement between industry and regulators like the CDSCO and US FDA is pivotal to increase the success rate of India’s biopharma companies. Edited excerpts …
Dr Patankar, there is a $75 billion biosimilars opportunity that is opening up due to the many biologics going off patent from 2022 to 2030. How do biosimilar companies in India ensure that they can leverage their strengths and maximise their opportunities during this period? What needs to be added to the ecosystem to ensure that companies in India do not miss this opportunity?
Firstly, I am not a big believer in the concept of a patent cliff because a patent cliff gives a sense of a fixed, one–time thing and then, it is never going to happen again. Which is not entirely true.
Blockbusters keep going off-patent at regular intervals and new blockbusters come in. So this will be an ongoing thing. It may be that certain years are particularly conducive because a number of blockbusters are going off-patent, so maybe such a cliff exists now, but we should not think of this as a now-or-never opportunity – these opportunities will keep coming up.
Secondly, when we say $75 billion, we should also keep in mind that that may be the peak sales of all of the products that are going off-patent. Not all products reach their peak at the same time. So at a given point in time, I don’t know whether that’s $75 billion in sales or not.
And thirdly, that’s at the price that’s prevailing in the market. When biosimilars come in and if everybody launches at 50 per cent (of the price), $75 billion becomes $37.5 billion. So we need to keep that in mind.
Absolutely. And I think that’s why governments and regulators are tracking it very closely because their mandate is to keep medicine prices down. Which is why they will create infrastructure and collaborations with industry. Because as you pointed out, the patent cliff is not a hit and miss opportunity, the ecosystem needs to be created beyond the patent cliff.
Exactly. But having said that, the opportunities are very significant. The Indian biosimilar industry is right now, probably less than a billion dollars. And there’s obviously a large headroom for growth.
And we should also look at it as helping patient access because the more the industry grows in manufacturing for global markets, they can invest more and make newer products and invest in innovation for more affordable access to healthcare for the Indian population. So it’s not only about the revenues but also access to healthcare for the large Indian population base, for which we need a very strong and healthy biologics and biosimilars industry.
Exports are important to business for two reasons. One is the larger market in terms of patient population, but also pricing. (If you consider) the pricing of the same biosimilar drugs in India versus Europe versus the US, there’s a several-fold difference. Europe is two or threefold of India and the US is another two or threefold of the European prices.
It is important for Indian companies to try and target the US market because they can get better pricing and better overall sales volumes, and become a stronger industry.
Currently, there are a handful of companies, probably seven or eight companies that have approvals in Europe. Unfortunately, that has not been the case with the US. There’s perhaps only one Indian company that has US approval.
What needs to be added to the ecosystem so that India-based biosimilar manufacturers can target the US market?
A number of (India’s biopharma) companies have received European approval, but have not managed to go to the US. There could be two or three reasons.
The first reason is the higher cost. Developing for the US market definitely requires more investment, so the Indian industry needs to become a little bit more ambitious. I believe that a lot of times the Indian industry is held back by their own unwillingness to take those investment risks. And I think Indian companies should feel more confident.
Given the successes that we have in Europe and the overall talent base and understanding of the Indian industry, which is at a good level. Of course, it will need more investment, but I think the Indian industry should develop more confidence about being able to go to the US market and should make those investments.
Why do you need more investments if you want to launch the same product in the European market and you want to take the same product to the US market? What exactly makes that whole process more expensive to launch in the US?
One issue currently, and this is a problem everywhere, is that both Europe and the US require clinical trials to be done in comparison with the product sourced from that respective market. Therefore you have to do a clinical trial for your biosimilar in comparison with European-sourced products to apply in Europe and with the US sourced product to apply in the US. Which means if you want to apply to both places, your costs go up because you’re running one extra arm of clinical study.
And then as I said earlier, the US cost of these drugs is much higher. So the cost of procuring the reference product for comparison itself is also higher. So there are these two reasons: one, that you have to do one more trial and secondly, that you have to then procure more expensive product.
Another factor is (lack of) awareness about FDA requirements and expectations. The success rate of Indian companies can go up if there is greater awareness of the FDA’s requirements and expectations. We need to increase engagement with the US FDA because you really need to understand each other. We need to become more aware of the FDA’s viewpoint, maybe the way they look at a dossier, maybe the way they look at GMP compliance when they come and inspect the manufacturing facility, maybe their approach or what they look for is a little bit different from what European authorities do, and our industry needs to understand that. The more we understand, the better we’ll be able to meet those expectations and we will have better success.
And conversely, they (FDA) also should be exposed to our industry. Today the FDA is exposed to the Indian generic small molecule pharma industry. So they come and participate. They speak to our regulators, tand hey come and attend conferences where they talk about what the FDA expects for product approvals, for GMP compliance, etc. They don’t do that for the biologics industry yet.
It will be good if they get to understand the Indian biologics industry, who are the players, how big it is, what the talent and capability base in India are, and what the regulatory pathways are. As they develop that understanding, they can engage with our regulators on harmonising some of the regulatory requirements, they can attend conferences, they can tell us more about what their expectations are. It is not that we cannot meet their expectations. It’s more about understanding what those expectations are and then focusing your efforts accordingly.
What is the Indian government doing on the biologics/biosimilars front? Is there a harmonisation of the biosimilar regulations in all these countries? Do we need country specific guidelines, some part is harmonised with the rest of the world because if you’re going to export to a certain market it has to be compliant with the laws of the destination market. But is there merit in having some part of the guidelines localised as well?
Yes. There needs to be harmonisation definitely to the extent that you’re not required to do unnecessary things if you’ve already done them for one market. An example is this clinical trial with reference products sourced from individual markets. A lot of effort is being put by industry, by lobbying groups and others all over the world to say having to do two clinical trials, one with the European–sourced product, and one with the US–sourced product, is not meaningful because usually the reference product is manufactured by one company in the same plant and supplied to both markets. I don’t think there has ever been a case where a product was found to be similar to the European product, but not similar to the US product. That just doesn’t happen. So those kinds of harmonisations are desirable.
Harmonisation is also desirable when it comes to demonstrating biosimilarity through analytical techniques, in terms of product quality. If multiple regulatory agencies have common standards of how to demonstrate biosimilarity, one, it eases the work of the companies by not having to repeat studies when they go to a new market, and secondly, it will ensure uniform quality of products. So if the Indian biosimilarity expectations are aligned with the US or EU, then it will also mean that the products approved and available in India will be of the same quality as those supplied to the global markets, which is very desirable.
However, coming to the Indian context, I think some localisation is necessary, just given the nature of the industry, which is maybe less mature in India. You have to also look at the spectrum of companies in India. You may have companies at the top end, very highly focused on the US and other global markets. They’re highly aware of the requirements, they’ve invested more, they have large plants, stronger compliance systems, more technical and scientific strength and they’re going for these global approvals.
And then at the other end, you have startups, you have smaller companies who have lesser ambitions. They want to be mainly India focused, but also they’re not as mature in their systems. So the Indian regulations have to, on the one hand, not be too burdensome, for the mature companies and that’s where the harmonisation comes in. But at the same time, they can’t forget the fact that the smaller companies may need a greater level of scrutiny, a more step-by-step approach, more hand-holding, and more defined rules, to make sure that they’re also complying with good quality standards and making the right kind of products for India.
Also from an access point of view, to make sure products are available and affordable, you need to make sure product development costs are not prohibitive. So you might want to make certain concessions and some practical considerations for what constitutes an acceptable, dossier for the Indian market. So some level of customisation or localisation, I think is appropriate within an overall context of harmonising.
You’ve had a ringside view of the biosimilars business developing in India. You’ve steered three very big companies Wockhart, Intas, and Syngene, in very different kinds of businesses. Can you share some examples of best practices to guide other industry participants?
I think the main thing that everybody should pursue today are two things: one, strong scientific and technical understanding and second, high standards of GMP compliance. Everyone must understand that there are no shortcuts to developing quality products. And, if you don’t invest early in understanding the science and having that scientific depth of capability, you run into problems in the long run. You may have later failures that you’re unable to resolve because you didn’t do a thorough job to begin with.
Also if you have a lackadaisical approach towards compliance and GMP that leads to problems later on when you try to expand to the larger global markets. We have seen that in the pharma industry where the Indian industry went through difficult times with FDA and other global agencies and created a bad reputation for Indian pharma. We do not want to repeat that kind of a problem with biosimilars. And I think the Indian patient has as much right to receive a high quality product as an international patient.
So I would say all companies, regardless of whether they are startups or small companies or large companies, and whether their immediate target is the Indian market or global market, should invest in good scientific depth, good capability building and good compliance. And, if you do that in your product development and manufacturing, then investments in clinical trials for various markets including the US can be decided based on your overall ability to invest, to take risks and so on.
But the risk should be in your ability to invest for these larger scale things (clinical trials, regulatory expenses and global marketing). You should not be taking risks in the basic aspects of product development and manufacturing and in delivering a quality product. Focusing on those two things, scientific depth and compliance, should be absolutely done by everybody. And done right from the beginning.
What is the role of conferences like Biologics 2025 in putting the industry on the right track from day one?
These conferences, I think, play a very big part. If you think of a company that’s less mature or starting out, how do they learn? Where do they get the scientific understanding? How do they learn from other people’s mistakes or other people’s successes? They learn by going to these conferences. You have sessions on manufacturing aspects, analytical techniques, on high end technologies. So you learn best practices, the hurdles, the technical challenges, the scientific understanding, you learn that very quickly through these conferences rather than making those mistakes and doing it over a slow period for several years.
And one good thing that has happened over the years is that Indian companies are now willing to share knowledge. In the very, very early days when everybody was fighting over the same two or three products that were going off patent, people felt that OK, if I have figured out something, I shouldn’t share it with others because then I’ll lose the competitive edge.
But I think now companies are working on diverse products. People are realising that sharing knowledge doesn’t cause them to lose a competitive edge. And because we’re also now competing in a global market, if I share something with another company in India, it’s not going to severely impact my overall sales business. Also, I’m just not sharing with others, but I’m also learning from others.
It’s a very good opportunity to learn at a conference, not only by listening to the lectures, but actually walking up to people, talking to them individually, saying, you know, I have this type of a challenge, how do I overcome it? And when you help someone else, you’re not disclosing serious IP or confidential matters, but you’re just helping people overcome their ongoing challenges.
The engagement with the regulators is another great benefit of being at the Biologics 2025 Goa conference. The regulators, and now I am talking about the Indian regulators, also come to know what your challenges are, and keep in mind that the regulators also need to upgrade themselves and keep up with the technology – What’s happening new, what are new enabling technologies coming up? What are the new risks that are being identified? So they also learn so that the next time around they can do a better job of asking the right questions, accepting newer technologies, and scrutinising certain things more because now some new risks have come up. So they also get to learn, they understand what the industry’s challenges are and where they can facilitate the industry’s progress without of course compromising anything on the product quality.
Globally there is a huge shift happening in biosimilar regulations. It is felt that asking for massive clinical trials is not useful because if you have a very solid analytical comparability and PK study, maybe you don’t need efficacy studies because they don’t tell you anything more. If anything, the differences between the biosimilar and the reference product are brought out more at the analytical level than in the clinical trial. We’ve already seen cases where clinical trials are being waived and over the next few years, this will become more common.
This is going to change the biosimilar industry because clinical efficacy trials are the largest component of the development cost. The entry barrier will, to that extent, come down in terms of investment, but the focus on product quality, analytical comparability, PK, and GMP will remain, or even strengthen. This represents a tremendous opportunity that the Indian biosimilar industry should seize. So a conference like this that brings together people talking about science, as well as regulation, is immensely important for our industry to move up to the next level and capitalise on this shift that is happening.
viveka.r@expressindia.com
viveka.roy3@gmail.com
Dr. Patankar’s insights highlight a crucial growth opportunity for India’s biopharma sector in the US market. Building confidence to take higher investment risks and fostering stronger engagement with regulators like the US FDA are essential steps.
This approach not only boosts revenues but also enhances global access to affordable healthcare, cementing India’s position as a leader in biosimilars.