In this Q&A, Dinakaran (Dina) Balasubramanian, head of commercial strategy and insights for biologics at Dr. Reddy’s Laboratories, says specialty generic drugs and biosimilars are driving the company’s future growth prospects.

Contract Pharma: What are your responsibilities now with Dr. Reddy’s Laboratories?

Dinakaran (Dina) Balasubramanian, Head of Commercial Strategy and Insights, Biologics, Dr. Reddy’s Laboratories: One of my primary responsibilities is developing commercialization strategy for biologics and being a thought partner for both the brand team and the market access team, involved in launching biosimilars. I’m also involved in developing forecasts for internal products and analyzing any licensing or acquisition opportunities which come to our table. I also closely monitor the biologics and biosimilar trends in an evolving and highly dynamic landscape.

So, that’s a summary on a broad level. I try and plug myself into anything that’s needed by the team in these areas to move things along. Our team is very involved in the early stages of our go to market model and framing our overall launch strategy.

CP: How long have you worked at Dr. Reddy’s Laboratories?

DB: I’m in my 7th year now as I joined the company in 2017. I started out with the active pharmaceutical ingredients, which is our API business. I was based in India for that role where I was head of India and Southeast Asia markets for sales and marketing for the API business. While that was my role in India, it’s a little misleading because my market focus was always regulated markets—U.S. and Europe. So, that’s how I got used to the regulatory landscape, IP landscape, and the whole product landscape in the U.S.

I added on Southeast Asia as an additional responsibility over time, which included countries like Malaysia, Indonesia, Thailand, and the Philippines.

That was my responsibility on the API team, and I had a couple of people who worked under me for the India market. From there I made a switch into the formulations business, into North America generics around 3.5 years ago. I moved in under Marc Kikuchi as a chief of staff and led strategy for the business. I had been a sales professional for almost my entire career of 8-9 years, this was my first role outside of sales, which enabled me to get into a strategy position and help Marc.

My role was to come up with a strategy review of the business and also identify adjacencies where North America could operate in. We were traditionally operating in the retail generics, institutional generics and the OTC store brands space. One of the asks from the senior management team was to look at what are the possible adjacencies that the business could have, and what are the areas that we could enter into. So, as an outcome to that exercise, there were two identified initiatives. One was biosimilars and the other was branded OTC or self-care/nutritional/dietary supplements. So, I analyzed a bunch of about 5 or 6 spaces, and the recommendation was to go ahead with these 2 spaces. Biosimilars was an outcome of that. And then things fell into place.

A lot of things were moving in the background as well as in India with respect to biosimilars in both the U.S. and European markets, commercializing the products ourselves, which led us to where we are today with biosimilars.

From there I moved into the specialty injectables business and took up the role of leading product management. I handled about 18 injectable products which included managing around 5-6 product launches. These products are spread across small molecule oncology injectables and general injectables.

This laid the foundation for me to understand the overall healthcare ecosystem in the U.S. Institutional business is a great window into how the hospitals function, and how the clinics function, how product moves through the channel, the market structure, different trade considerations, contracts, pricing, and reimbursement. Product launches that I handled helped me understand the marketplace and its nuances thoroughly. This helped tremendously in my understanding of the biosimilar market landscape as it had a few additional layers to what we were already doing in the generic injectable space.

Then, the decision was made now that we’ve gathered enough momentum on biosimilars, and with their launch coming in the next 1-2 years, there was an organizational need to carve out the roles separately. So, that’s what prompted my switch into my current role where I would be leading the commercial strategy for biosimilars.

CP: When you first started working with Dr. Reddy’s did you think you would end up working in the U.S.?

DB: Well, yes and no, because the answer lies in what I used to do prior to joining Dr. Reddy’s. In my previous company, I was promoting products and services related to drug serialization for pharmaceutical companies. It was then that I had understood a lot about the U.S. market working with companies on DSCSA. I always had one leg in the U.S. market, and I was always on the lookout for opportunities in the U.S. because I thought that’s where I could build on my market knowledge and my career.

CP: The segment that you handle now is specialty Gx and biosimilars. Is that a growing piece of the Dr. Reddy’s business?

DB: Absolutely. I think that’s where the future growth is going to come from. I would say within the generic segment there are a few products which are complex and where we have been one of the few players that have launched products that have been extremely valuable in the past 5-7 years. Specialty generics and biosimilars are very complex and expected to generate a lot of value for the business going forward. At the same time, the biosimilar space is exploding, simply because of the heavy innovator pipeline in biologic therapies and patents of many big blockbuster biologic drugs expiring.

The treatments in biologic drugs are expanding beyond the traditional treatment landscape of oncology and immunology into other therapy areas as well. So, there is an explosion of drugs in the biologic segment. As a follower, the place to be is biosimilars for us, because of the sheer number of products and the value of the products that exist in that space.

Biosimilars are going to be looked at as one of the biggest growth areas for Dr. Reddy’s in the U.S. as well as globally. I firmly believe that this is where the big growth opportunities exist in the future.

CP: In your position at Dr. Reddy’s, what do you feel are the most important skills that you need to handle your responsibilities?

DB: That’s a good question. I think one of the most important skills is a thorough understanding of the U.S. healthcare ecosystem. As a generic company we have been more focused on selling to the channels through wholesalers/retailers. Generic drugs are covered by payors, by default and are fully substitutable at a pharmacy level. This led to the distribution channel being the most important stakeholder. Payor reimbursements and patient out of pocket costs were largely out of my purview. However, biosimilars are treated like quasi brands as they are not fully substitutable. This demands an expanded understanding of the payor driven healthcare market and key incentives at play for the various stakeholders like payors/providers/patients.

You need a good understanding of the patient ecosystem and the site of care where the patient gets the treatment. Both are part of the big picture, and you need a thorough understanding of each. This is one of the biggest requirements for the role which I’m currently in, and for which I’m learning on the go.

That’s one major thing. Another, which I would say is something that I’ve picked up over the years, is to battle through the depth and details of things. But, at the same time not to lose sight of the larger picture of what we’re trying to accomplish as a business, which is another key aspect of the role.

CP: How did your way of doing business change during COVID?

DB: Let me back up a little to answer that question. Around 2014-2015 there was an inflection point for the industry, and prior to that customer consolidation hadn’t happened. So, there were a lot more institutions. The market was a little more fragmented, so there was a lot of parity between the buying entities and the selling entities. That used to be the business model prior to the 2014-2015 timeframe, post which there has been a huge wave of consolidation and vertical integration among players in the distribution channel. Large buying consortiums formed and began to squeeze generic companies for margins. Increased competition among generic companies further added to the woes. Price became the only lever for negotiations.

During COVID, supply chains across the globe were disrupted and pharma was no exception. This exposed frailties of many manufacturers, which led to buyers evaluating suppliers more holistically and not just relying on price. Factors like consistency of supplies, backward integration, and supply resilience started getting featured into the bidding process, which is a good thing. During COVID I would say that price erosion was a little softer because many suppliers were worried about supply consistency. They didn’t want to rock the boat too much. So, if someone was supplying them and they were getting volumes, they didn’t want to punish them and do a price negotiation. For a few dollars here and there they wouldn’t switch. There was kind of a stability for about two years. I think that effect has kind of worn out now but thrust on supply consistency has remained.

What you’re seeing now is the more robust the supply chain you’re able to present to the customer as a manufacturer, the better your chances are and it’s not only about price. So that is a landmark shift which just happened post COVID.

CP: For the specialty Gx biosimilars, do you also get involved in your job as far as the support services that Dr. Reddy’s offers to patients and providers?

DB: Yes, we did that in a very limited manner for the specialty generics portfolio, but there are a lot of price considerations and complications. Still, you should be able to match the patient support services that are being provided by the brands.

CP: Do biosimilars take longer to get FDA approval?

DB: Yes, invariably the development cycles are much longer. This is primarily because of the need for clinical studies for biosimilar approvals. In the case of small molecule generic approval bioequivalent studies are enough to demonstrate sameness, in the case of biosimilars, clinical studies are required to prove similarity and safety and efficacy profile of biosimilars.

So that adds to the program development timeline and the approval pathway becomes longer in terms of once you begin the review process. The preparation time for a submission is much longer in the case of biosimilars.

CP: What is the number one most challenging part of your job?

DB: To answer the most challenging part I would say understanding the changing landscape, especially the biosimilars landscape. To give some background, the first biosimilar in the U.S. was launched somewhere around 2015. That’s not too long ago. So, it’s still early in terms of biosimilars as it’s still an evolving category. There have been a lot of changes that have happened on the policy front, changing legislation, and the FDA regulatory point of view is constantly changing.

Globally there are a lot of developments happening with respect to biosimilars. People are starting to question the existing development process approval pathway. So, it’s still in its very early days. There’s a lot of moving parts to keep track of, and reacting and responding to those changes with your internal moves is very challenging. You can’t ignore any signal which comes from a market, because that could result in a wrong investment decision, and it could come back to bite you later.

So, I would say that the most challenging part is to keep up with the changing trends and to reflect on those trends and project as to what will happen in the future and how you should be prepared for that. It’s the most challenging part, and I think the most rewarding part, because you have to be on your toes with respect to understanding what’s changing in the marketplace.

I’d like to give a couple of examples of this. Say for example, UK just came up with a guideline saying that you don’t need Phase 3 trials anymore. You do a Phase 1 trial, prove your biosimilarity, and you’re good to apply for registration. So, that’s a landmark change or shift because that’s one of the first regulated markets to have made that change. If that change were to come to the U.S., suddenly you’re talking about the cost of development going down drastically. If that happens, the market would become even more competitive than today. The repercussions that you could have in the U.S. market would be very interesting to watch.

These are the kinds of challenges that I love, and the kind of challenges I believe are more rewarding because you’re staying ahead of the market, and you can also add value.