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Tony Mauro
PITTSBURGH — Over the course of the past decade, Mylan has succeeded in refining and expanding its business model in pursuit of the goal of improving access to medications and addressing gaps in the market. Still thought of by many people as primarily a supplier of generic drugs, the field in which the company first rose to prominence, Mylan has developed a robust presence in brand-name pharmaceuticals, biosimilars and over-the-counter health care products.
Tony Mauro, the company’s chief commercial officer since January 2016, is one of the people who have driven that evolution.
“A decade ago we saw that the industry in the U.S. was changing dramatically,” recalls Mauro, who has served in a number of pivotal roles, including president of North America and president of Mylan Pharmaceuticals, the company’s U.S. generics business, during his 24 years at the company. “We saw that competition was intensifying and customers were merging. We saw the distinction between the traditional branded and generics companies was starting to blur.
“We saw a future where hybrid products were going to be very important for the company to grow and to innovate. And we saw that, at the same time, advances in science were really creating opportunities that would reward long-term, wise investment. The burden on health care systems was also growing, not just in the U.S., but everywhere. So at that time we embarked on a journey to navigate through these changes and build a model for Mylan that we felt would be good not just for the next few years, but for decades beyond.”
The diversification strategy developed by chief executive officer Heather Bresch and her team has given Mylan a compelling range of capabilities. The company has 12 research centers and some 3,700 medications in development or awaiting regulatory approval. It sells 7,500 products around the world in 10 major therapeutic categories, including treatments for cardiovascular disease, central nervous system disorders, diabetes and women’s health.
“We set out to create a durable business model, one that would harness the power of both competition and innovation to drive access,” Mauro explains. “Access is a huge part of our mission at Mylan. We operate in 165 countries around the world right now, and getting high-quality medicine to 7 billion people is very critical to what we do.
“It really was about globalizing, using that skill in R&D and our active pharmaceutical business, and then our finished dosage form business and manufacturing capabilities to diversify. At the same time, ensuring our commitment to quality was always the rock on which we stood.”
All of the changes at Mylan in recent years have not caused the company to neglect the generic drug business, which accounts for approximately 75% of sales in this country and 40% globally. The impact of the three big generics purchasing organizations — Red Oak Sourcing, Walgreens Boots Alliance Development GmbH and ClarusONE Sourcing Services — has triggered deflation in the generics market, but Mauro sees opportunities as well as challenges in the sector.
“There has been enormous consolidation in our customer base over the last decade,” he acknowledges, “and I wouldn’t say that we haven’t been without some price erosion, which we’ve reported publicly over the last few years. But with our broad product portfolio and scale, we have the diversity and durability to continue to play a leading role in the generics market, and partner in a holistic manner with these three big buying groups and other customers.”
Mylan’s proven ability to effectively bring low-cost generics in major therapeutic categories to market is another mainstay of the company. The recent introduction of Wixela Inhub, the first generic equivalent of GlaxoSmithKline’s ADVAIR DISKUS to win Food and Drug Administration approval, illustrates the point.
“We’ve had numerous discussions with customers about the need for a unique launch strategy for the first substitutable generic of ADVAIR DISKUS that increases affordability to all in our health care system,” Mauro said in February, when the treatment for asthma and chronic obstructive pulmonary disease (COPD) received the green light from the FDA. “We trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the U.S. health care system overall.”
In addition to working to limit the price of Wixela Inhub, Mylan is offering patient services to provide training and education about the treatment and device.
“We’ve seen enormous success post-launch,” Mauro notes, “and one of the critical factors is our partnership with these consolidated generics buying groups. We’ve made a $700 million-plus investment in bringing the product to market.
“We want to ensure that we can achieve proper conversion for that product in the marketplace. The way you do that is by setting the right pricing strategy to drive affordability and reach for patients and for payers, but, at the same time, working with community pharmacies. They have to be an active partner for success.”
Mauro says that the increasing prevalence of medications like Wixela Inhub, which he refers to as hybrid products, requires a new level of support and engagement from drug makers and their partners in the supply chain.
“When I talk about hybrids, I mean products that may be like a traditional generic in some ways, but may also be like a brand as well,” he explains. “These products require a dedicated salesforce to physicians, medical resources and a higher-level hub services where there is a more hands-on approach to the patient in terms of connectivity as well as reimbursement support. These aren’t traditional, generic products. Hybrid products take a lot more investment, a lot more planning, not just in research and development, but in the execution of the commercialization process.”
The emerging field of biosimilars comes under that umbrella. Mylan currently has 20 biosimilar treatments on the market or under development, according to Mauro, and sees great opportunity in the sector.
“They represent a huge part of our R&D investment. Of the top 12 costliest biologics in the world, we have nine biosimilars or insulin products on the market or in our pipeline,” he says. “They’re products like insulin and biosimilar versions of [Abbvie’s] Humira and [Amgen’s] Enbrel, all of which will require more than a traditional generics launch would.
“When you look at where there is opportunity to grow in generics in the U.S. and globally right now, it’s biosimilars. IQVIA reports that biologics represent 40% of the total pharmaceutical spend. Those products are very expensive to develop, very expensive to manufacture, and the commercialization process requires an enormous amount of planning and investment, but, at the same time, they enhance affordability and represent tremendous value. Traditional generics companies are really going to have to up their game.”
Mylan is meeting the challenge head on, supporting the work of its partners in retail pharmacy by interacting with specialized patient populations. That process is facilitated by technology.
“We connect with high-touch patients through digital assets,” notes Mauro. “We have product websites. We have training kits for patients and physician education. For generic Glatiramer Acetate we have a hub service called Mylan Advocate that includes an interactive mobile app, in-home injection training, a 24/7 patient support center and ongoing support from an MS-experienced nurse. We want to do anything we can to help drive greater acceptance, compliance and adherence to these very expensive products.
“At the same time, we always strive to provide adequate affordability. That’s where it’s going to be a challenge on some of these hybrid products, which again are not brands and not traditional generics. We want to provide best-in-class service and innovation from the perspective of how you surround patients with everything they need to be successful to treat this disease. But, at the same time, you have to be thoughtful because you want to drive affordability.”
Mylan works closely with drug chains and other retail pharmacy operators to shape the future of pharmaceutical care. In so doing, the supplier brings the same long-term view it takes in running its own business.
“We have established a regimen where we talk about our product pipeline with our customers as frequently as we can from a timing and knowledge perspective,” Mauro says. “Although we never know for sure when the FDA will act, we provide as much insight as we can. We always keep our pharmacy partners very close, because we know what they do is so important to the patients that we both serve together. But it’s also about how they manage their inventory and think about their own budget and planning process.
“We try to meet with big customers at least once a quarter, and talk about how we can work closely not just the next 12 months but the next five years. We want to identify where they might have services and offerings that we can help make more holistic in terms of how we work together to deliver knowledge, education and savings at the point of care.”
The ability to understand where health care is headed and adapt to changing market conditions has served Mylan well but, according to Mauro, there’s no room for complacency.
“We’re starting to see many of those investments that we’ve made over the last decade become reality today,” he says, “and we’re seeing the evolution of our portfolio deliver on some of that long-term value. We’ll continue to invest, especially in complex products, because we see that’s where the trend in the spend is going. It will require additional allocations of capital into these areas.
“Innovation is pivotal to Mylan’s ability to expand access to medicines, which is the fundamental role we have across the world. We review our product portfolio and our network of manufacturing and supply chain assets quarterly. We want to make sure our products are helping address unmet needs. A very important piece of this is looking at where there are gaps in care and how we can meet them.
“That’s why it’s not uncommon for us to be among the first to manufacture these difficult-to-make generic products that many avoid because of the costs and risks involved. But we know how critical those medications are to driving down overall health care costs. If they do that, specifically at point of dispensing, the point of care for the patient, they’re going to be a win for everybody involved in the system.”
