Milan Kalawadia: Carving Out New Pathways

Milan Kalawadia, CEO, North America, Dr. Reddy’s Laboratories

Dr. Reddy’s Laboratories, the India-based pharmaceutical power, has always made sure not to stray too far from the fundamental roots and purpose its business was founded on more than four decades ago: serve as a major global supplier of generic medicines and active pharmaceutical ingredients. But, when examining the organization’s evolution, that doesn’t mean the multinational manufacturer has rested on its laurels.

Take the Dr. Reddy’s North America Group, for example. The US arm, today guided by CEO Milan Kalawadia, started initially in retail prescription generics, added capability in private-label over-the-counter (OTC) products, and then expanded into hospital/institutional injectable generics.

And even as those core verticals continue to drive the unit’s growth pursuits, in formulating its strategic vision for the future, the company, like many, recognizes that operating successfully will require stepping deeper into new territories and further stretching boundaries centered on innovation and collaboration.

“Ultimately, the goal in all that we do within North America is, how do we add value or provide benefits to patients in terms of giving access to products and medicines that are required or needed?” Kalawadia tells Pharmaceutical Executive in an interview.

The longtime Dr. Reddy’s employee has been formally steering such efforts in the US since late May 2024, when he was appointed CEO of North America, with operations headquartered in Princeton, NJ. During a 19-year tenure at Dr. Reddy’s, Kalawadia, a native of New Jersey whose parents immigrated from India in the early 1960s, has held various positions of increasing responsibility. Prior to CEO, he served as chief commercial officer, responsible for the customer-facing operations of the three business verticals noted earlier.

It was this track record and experience, combined with his steady hand as CCO during the early development of two new growth initiatives at Dr. Reddy’s—biosimilars and self-care and wellness—that made Kalawadia a natural fit to take the helm as CEO of North America and guide these strategies forward.

“The interesting part is going deeper to that next level—digging into why things are happening and getting into shaping the direction, narratives, strategy, and focus areas for those related divisions,” says Kalawadia, who adds that he continues to work closely with many of the same team members he did during his prior role.

“I am now embracing a different aspect of the role,” he notes. “The beauty of my prior role running the commercial division, was that I had to be engaged in various aspects beyond the customer, from FDA matters related to approval, discussions regarding inspections of our facilities in India, supply chain management matters, etc. All the efforts of our cross-functional teams have always tied back to the customer or the product at the end of the day—which ultimately impacts the patient.”

Feeding commercial fortunes the most continues to be Dr. Reddy’s legacy brand OTC/direct-to-consumer (DTC) franchise, which, across the larger organization, drives more than 80% of its revenue. Worldwide, Dr. Reddy’s offers more than 400 generic drugs in several therapeutic areas, including gastroenterology, cardiovascular, diabetes, oncology, pain management, and dermatology. The Dr. Reddy’s pipeline includes new chemical entities that focus on therapies for metabolic disorders, bacterial infections, pain, and inflammation.

The company’s official marketing territories cover the US, Europe, Latin America, and Asia. Along with the Princeton location, Dr. Reddy’s has R&D centers in Leiden, Netherlands; Cambridge, UK; and at its global home base in Hyderabad, India.

In third-quarter, fiscal-year 2025 earnings released in January, Dr. Reddy’s posted a revenue increase of 16% compared to the same period the previous year. The US accounts for a 40% share of the sales, followed by emerging markets, at 17%, and India, at 16%. According to a report on StockEdge, the company’s revenue has increased at a compound annual growth rate of 12% in the last five years, while net profit has jumped 39% (3QFY25 results not reflected).

Growth formula

A major focus for Kalawadia is shepherding new pathways for growth. In the immediate term, that includes carving out the two new business units mentioned: biosimilars and self-care and wellness. Pacing efforts in biosimilars is a concerted push to expand beyond the emerging, or ex-US non-developed markets, that Dr. Reddy’s has traditionally played in in this space. To that end, the company’s US team is making progress in advancing biosimilar drug candidates in oncology and rheumatology.

Notably, during the last quarter, Alvotech, Dr. Reddy’s partner on a version of Amgen’s Prolia (denosumab) for osteoporosis, completed regulatory filings in the US and Europe. According to Kalawadia, the Dr. Reddy’s unit is also advancing a biosimilar candidate of Bristol Myers Squibb’s disease-modifying drug Orencia (abatacept) for rheumatoid arthritis. The originator product is also indicated for psoriatic arthritis and polyarticular juvenile idiopathic arthritis.

A published report by Precedence Research calculates the global biosimilars market at $40.36 billion in 2025 and forecasts totals as high as $176 billion by 2034. Following a prolonged stretch of sputtering activity, the biosimilars market in the US has been building steady momentum in recent years. After surging approval outputs in 2023, including nine biosimilars of AbbVie’s immunology giant Humira, the FDA cleared 19 follow-on biologics in 2024 across various therapeutic areas.

“Biosimilars, if you think about it, are still in their infancy,” says Kalawadia. “I would anticipate a lot of evolution. Many global regulatory authorities are trying to assess how to continue to enable biosimilars to come to market.”

Highlighting pursuits on the self-care and wellness front, Dr. Reddy’s is leveraging its platform play with Amazon’s online pharmacy store. The program involves making Dr. Reddy’s legacy generic OTC products (i.e., allergy relievers, analgesics, and antacids) available to patients under an umbrella brand, which the drugmaker calls HealthCareAisle. According to Kalawadia, activity around the DTC channel, housed separately from Amazon Pharmacy, has accelerated over the last 18 months as Dr. Reddy’s “puts some energy and muscle into marketing efforts to accelerate the brand growth on the Amazon platform.”

“This is an area that we believe has a lot of potential and we’re placing a significant bet on,” he adds.

Kalawadia acknowledges that, broadly, the DTC landscape in healthcare has transformed significantly in recent years, with various stakeholders tapping new digital tools in professed efforts to boost patient access and affordability. Whether, for example, it’s Big Pharma companies such as Eli Lilly and Pfizer launching their own dedicated DTC platforms offering disease management resources and home delivery of select popular medicines. Or the emergence of Amazon Pharmacy and other alternative pharmacy models, such as Mark Cuban’s Cost Plus Drug Company, that sell prescription medicines (primarily generics, in Cost Plus Drug’s case) directly to patients at discounted prices.

“You’re seeing evolving models,” Kalawadia tells Pharm Exec. “Branded pharma is going to still continue down the traditional approaches, but the way that I see it is that everybody’s keeping a pulse on the marketplace, the dynamics of these disruptive players, and seeing what space they may need to bet on or at least monitor.”

Kalawadia includes Dr. Reddy’s in that group keeping a close watch.

“We obviously play in the traditional marketplaces or channels that you would imagine a generic player to be a part of. But we also do engage with these new, disruptive models that are emerging to ensure that we have a part of the evolving dynamics of our industry,” he says. “We have had conversations with or are partnered with a number of these alternate business models to date.”

Women’s health is another component of the wellness initiative the CEO is helping to build out. Keying that effort initially was the company’s January 2024 acquisition of MenoLabs, a women’s health and dietary supplement brand from Amyris, Inc. Dr. Reddy’s acquired the entire MenoLabs supplements portfolio, which included seven branded products designed to provide health support and address the symptoms of perimenopause and menopause. The deal also included the MenoLife health tracker app that supports the product line and provides community education and information to consumers regarding menopause. Dr. Reddy’s portfolio also features the women’s health brand Premama Wellness. The DTC platform provides prenatal and postnatal care products, as well as resources to support various starting points along the path to parenthood.

“We’re constructing a direct-to-consumer organization by leveraging some of the past learnings we’ve had from the private label space,” sums up Kalawadia on the company’s strategy for accelerating these growth initiatives, and aligning with OTC and legacy brand assets. “We believe we have an opportunity to be a meaningful player in each one of these areas—and carve out spaces within them that we can contribute and provide benefits to patients.”

Bullish on biosimilars

As alluded earlier, Dr. Reddy’s has a longtime presence in the biosimilars space. In 2008, the company launched Reditux in India, its biosimilar to Rituxan (rituximab). Famously, in 1997, rituximab became the first-ever approved monoclonal antibody for treating cancer. In all, Dr. Reddy’s markets four biosimilar products in several countries, and boasts an active development pipeline.

Focused in the latter, Dr. Reddy’s established a collaboration in February with Shanghai Henlius Biotech, Inc. around the development and commercialization of HLX15, Henlius’s investigational biosimilar to Darzalex (daratumumab) and Darzalex Faspro (daratumumab and hyaluronidase fihj) for multiple myeloma. HLX15, a recombinant anti-CD38 injection, met its primary endpoint in a Phase I clinical trial, demonstrating similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and China-sourced daratumumab. Comparative efficacy studies are currently underway, according to the company. Under terms of the deal, Dr. Reddy’s gains exclusive rights to commercialize the subcutaneous and intravenous formulations of HLX15 in the US and Europe, if approved.

In conjunction with HLX15, Kalawadia and the US team, via projects such as the aforementioned denosumab and abatacept candidates, is charged with accelerating the growth of the Dr. Reddy’s biosimilars business in regulated markets. That process began with the launch of a follow-on drug to pegfilgrastim for neutropenia in 2023 through a US partner, and the launch of a version of cancer treatment Avastin (bevacizumab) last year in the UK.

In the US, as noted, biosimilar acceptance and availability has improved. But hurdles remain—from clinical testing to market access—that are limiting wider adoption by healthcare professionals (HCPs) and use by patients.

“Currently, to bring a biosimilar to market is roughly a $150 million investment,” Kalawadia tells Pharm Exec, spotlighting the manufacturer impact. “There’s a high cost to develop, but the value still exists today, and you have to pick your bets.”

From the HCP vantage point, Kalawadia understands the initial hesitancy of some to switch a patient over to a biosimilar—“because you want to ensure that the medications you’re providing are actually going to perform in the same fashion as the innovator assets.”

“Comfort is a space that takes a little bit of time to get to, but biosimilars are proving through the Phase I and Phase III clinical trial requirements that they are equivalent or similar,” he adds.

Kalawadia is referring to the positive steps regulators have taken to expedite the biosimilar approval pathway, including those by the FDA. Although, while perhaps changing soon, key requirement differences between the US and non-US agencies still exist, he notes. For example, in some cases (i.e., the UK’s Medicines and Healthcare products Regulatory Agency), Phase III confirmatory trials are not required for market approval.

“My understanding when I talk to my regulatory team, is there hasn’t been a biosimilar in the US that’s passed Phase I that hasn’t also passed Phase III clinical trials,” says Kalawadia. “So I think it’s just a matter of time before the comfort and the confidence emerge behind the data that’s being generated. If the ultimate goal is access, then [removing the Phase III requirement in the US] is a direction that we may ultimately need to head down.”

Tackling change

Kalawadia’s 20-plus years in the industry offers him a unique lens on its evolution (he started as a financial analyst with Merck after stints at Deloitte and a healthcare startup). Reflecting on the generics sector, he cites increased competition and the consolidation of buying groups as the two most influential changes to the landscape over the years.

“The ticket to win here is providing robust products with the highest level of quality, on time, first to market, and at competitive pricing,” he tells Pharm Exec. “From a generics standpoint, if you can hit on those three pillars of price, quality, and speed, you are a reliable supplier. Then, relationships are important.”

For Dr. Reddy’s, the latter includes forging trusted alliances with third-party partners across pharma logistics, product portfolio management, manufacturing, and R&D, among other areas. Finding new ways to elevate efficiency internally is critical as well, adds Kalawadia—whether, for example, in manpower or improving processes. Carrying out such tasks, of course, was particularly crucial during the COVID-19 pandemic when pharma supply chain channels were greatly hampered, and quick-pivot decision-making was paramount.

Today, post-COVID lessons continue to roll in for drugmakers, the CEO notes. Such learnings have aided efforts to strengthen individual company supply chains and bolster mitigation strategies for taking on the next global health emergency. For Dr. Reddy’s, that includes a focus on optimizing stocking and service levels, technology, shipping routes and delivery, and risk assessment of supplier materials for its finished products.

“We’ve put in place machinery and processes, enabling automation for large-run products,” says Kalawadia. “Once the ‘recipe’ is in the system, the product is running at full speed without human intervention. Data is being reported back into a database on how things are progressing and we’re able to monitor the outcome. ... I don’t think you’re ever done finding efficiencies or finding improvements. We need to make sure our products are available for our customers and for our patients when they need them.”

Instilling a similar sense of urgency and purpose into the Dr. Reddy’s cultural fabric has become the norm for senior leadership, he adds.

“My role is to help define strategies, support the team, coach the team, and help us ultimately meet the objectives for North America, but even more importantly, for Dr. Reddy’s as a whole,” says Kalawadia, who visits the company’s global headquarters quarterly. “As a leader, especially as senior management, you’re not expected to have all the answers, but you have to have the right team around you that can support, enable, and take the vision and mission and move them forward."