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Dinakaran (Dina) Balasubramanian, head of commercial strategy and insights for biologics at Dr. Reddy’s Laboratories, spoke with Chain Drug Review about his role at the drug maker and how specialty generic drugs and biosimilars are fueling growth for it.
Dinakaran (Dina) Balasubramanian
CDR: What are your responsibilities now with Dr. Reddy’s Laboratories?
BALASUBRAMANIAN: 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/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.
CDR: What was your initial role with the North American business?
BALASUBRAMANIAN: My role was to come up with a strategy review of the business and also identify adjacencies where we could operate. We were traditionally operating in the retail generics, institutional generics and the O-T-C 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 O-T-C or self-care/nutritional/dietary supplements. So, I analyzed a bunch of about five or six spaces, and the recommendation was to go ahead with these two 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 five or six product launches. These products are spread across small molecule oncology injectables and general injectables.
This kind of laid the foundation for me to understand the overall health care ecosystem in the United States. Institutional business is a great window into how the hospitals function, and how the clinics function, how product moves through the channel, what was 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.
And then the decision was made that now that we’ve gathered enough momentum on biosimilars, and with their launch coming in the next one or two 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.
CDR: The segment that you handle now is specialty GX and biosimilars. Is that a growing piece of the Dr. Reddy’s business?
BALASUBRAMANIAN: 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 five to seven years. Specialty generics and biosimilars are very complex and expected to generate a lot of value lines for the business going forward,. 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.
CDR: In your position at Dr. Reddy’s, what do you feel are the most important skills that you need to handle your responsibilities?
BALASUBRAMANIAN: That’s a good question. I think one of the most important skills is a thorough understanding of the U.S. health care 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 health care 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.
CDR: How did your way of doing business change during COVID?
BALASUBRAMANIAN: Let me back up a little to answer that question. Around 2014 to 2015 there was an inflection point for the industry, 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 to 2015 time frame, 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 buyers to evaluate suppliers more holistically and not just rely on price. Factors like consistency of supplies, backward integration, 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.
CDR: 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?
BALASUBRAMANIAN: 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.
CDR: Do biosimilars take longer to get FDA approval?
BALASUBRAMANIAN: 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 time line, 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.
CDR: And the last question I have is what would you say are, No. 1, the most challenging and, No. 2, the most rewarding parts of your job?
BALASUBRAMANIAN: 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, the U.K. 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. And 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.
So, these are the kinds of challenges that I love, and these are the kind of challenges I believe are more rewarding because you’re staying ahead of the market, and you can also add value.
CDR: Do you want to add anything about the rewarding part of your job?
BALASUBRAMANIAN: The rewarding part of my job to me is the whole journey that I’ve had with Dr. Reddy’s. This has been very gratifying to me. If somebody had told me that I would be working with biosimilar launches in the U.S. market when I joined the organization six years ago, I would have taken it without question. I have a great regard for the organization because they value effort. They value the promise that you show as an individual to learn, and they’re willing to offer you roles and opportunities which match up to your desire and ambition.
