Hillary Clinton unveiled her strategy to rein in the high cost of prescription medication this week and revealed that one of her policy initiatives will be to increase Food and Drug Administration funding necessary to more quickly approve generic medications.
If Clinton eventually lands in the White House and makes good on her promise, then some of healthcare's biggest winners could be generic drugmakers including Mylan NV (MYL), Novartis (NVS 1.34%), and Pfizer (PFE 1.00%).
First, a bit of background
When drugs are approved in America, they hit the market with protection provided by both patents granted by the U.S. Patent Office, which last 20 years, and exclusivity periods granted by the FDA that vary depending on the drug and the addressable patient population.
Generally, patents offer the longest market insulation for drug developers; however, when patents end, generic manufacturers can file abbreviated new drug applications for their own versions.
In the case of small molecule drugs that are made with chemicals, the generic versions are identical to the branded drug. In the case of biologics that are more complex and created in living cells, the generic versions, known as biosimilars, aren't identical but are similar enough to deliver the same efficacy and safety.
Mylan and Novartis, through its Sandoz unit, are big players in generic small molecule drug market and Mylan, Novartis, and Pfizer, through its recently acquired Hospira unit, are all angling to be leaders in the fast-growing biosimilars market.
A big opportunity, but roadblocks remain
A boom of small molecule drug development in the '90s and early led to a massive wave of patent expirations over the past five years that is commonly referred to as the "patent cliff."
The patent cliff's peak was 2012, during which $53 billion in brand-name drugs lost their patent protection, but patent expirations continue to total in the tens of billions annually, including $44 billion in 2015.
As patents have expired, generic drugmakers have seen their sales skyrocket. For instance, Mylan NV has seen its annual sales climb to $7.7 billion from less than $1.5 billion a decade ago and Novartis has similarly enjoyed robust growth thanks to Sandoz, which contributed $4.5 billion to Novartis' top line through the first two quarters of 2015.
Clearly, the revenue growth associated with small molecule drug-patent expirations has been a bonanza for generic drugmakers, but an even bigger opportunity may be coming in biosimilars.
An astonishing $100 billion of biologics revenue will lose patent protection in the next five years, including more than $50 billion in revenue generated in America, and because biosimilars could deliver billions in additional sales to generic drugmakers, companies are flocking to develop them, including Pfizer, which spent $17 billion buying biosimilars leader Hospira earlier this year.
Although the opportunity for generic drugmakers is big, there's a major obstacle that needs to be overcome for them to maximize sales, and correspondingly reduce healthcare spending.
According to the Healthcare Supply Chain Association, the time it takes the FDA to review an application for approval of a generic medicine has increased to 42 months from 31 months in 2012 and that's leading to fewer generic drug applications being approved every year. That delay in approval time is the result of an increasing number of small molecule drug applications being filed as a result of the patent cliff and a lack of additional funding.
Unless the FDA's generic backlog can be cleared, the upcoming wave of biologic patent expirations will compound the problem, leading to potential delays in the availability of them, too.
That would be a shame because biologics are among the most expensive medicines on the planet and, therefore, approvals of biosimilars will have a significant positive impact on global healthcare spending.
In 2013, the average biologic cost payers $45 per day, while the average small-molecule drug cost payers just $2 per day. That cost difference is likely far higher today following the launch of therapies for cancer and hepatitis C boasting sky-high price tags in the past year.
Because spending on specialty drugs accounts for 1% of prescriptions, but 31.8% of all drug spending, and biosimilars are expected to be priced at a 30% discount to their brand-name counterpart, pharmacy benefit manager Express Scripts believes that if just 11 biosimilars to top-selling biologics get FDA approval, payers and patients could save as much as $250 billion through 2024.
As part of Hillary Clinton's plan to curb drug price cost increases, she plans to boost FDA funding to clear the generic drug backlog. If so, then Mylan, Novartis, and Pfizer will benefit from more drugs hitting the market more quickly than they are today.
In addition to funding, other initiatives that could help speed along approval times at the agency ought to be considered as well, including strategies that prioritize the approval of generic alternatives to medicines with the highest costs or the fastest-growing costs. Such a prioritization plan could save a substantial amount of money given that drugmakers typically hike their drug prices in the final years ahead of patent expiration.
Overall, because of the ongoing demand growth tied to a larger and longer living America, generic drugmakers like these three could be winners regardless of who becomes president.