September 9, 2016 at 5:00 am ET
As focus and attention related to the affordability of prescription drugs continues, it is incumbent on Congress, regulators and the health care industry to foster a robust and competitive marketplace. Within the current debate, there is increasing recognition from many different stakeholder groups that competition — from generic and biosimilar medicines — can mitigate the rising cost of brand drugs, and even more importantly ensure patient access to life-saving and life-enhancing medicines.
This week, experts gathered at the inaugural Biosimilars Council conference: Leading on Biosimilars, here in Washington. Two themes were shared repeatedly by industry thought leaders: Biosimilars are medicines that patients and providers can trust; and, more education is needed to ensure policy decisions moving forward are based on the sound science relied upon to develop and approve these medicines.
According to a recent survey, a number of industry experts view biosimilars as the pharmaceutical industry’s number one growth driver. The investments made by companies developing biosimilars have the ability to create market competition in the biologic sector, which would serve to increase patient access and choice while simultaneously driving down costs, just as Congress did in 1984 when the Hatch Waxman Act created the framework which has governed the modern-day generic drug industry. As safe and effective biosimilar versions of drugs such as Humira and Remicade are approved and become available, market competition will force lower prices and yield significant savings for patients, payers and the health care system. This is consistent with what generic competition has done for the past 32 years.
That said, the benefits associated with the development of a robust biosimilars market in the United States should not be assumed or taken as a given. Policymakers must be forward-thinking in setting policies that encourage a dynamic, thriving biosimilars market, and avoid decisions that could have a chilling effect on competition. In doing so, they need to be mindful of certain voices that, while claiming to be supportive of biosimilars coming to market, in reality are supporting policies that would delay or inhibit market entry for this new class of medicines. Such tactics not only serve to undermine the FDA approval process, but they seek to suppress biosimilar uptake.
The good news is that many are confident that over time, the science will win out, and overcome attempts to preserve certain biologic monopolies, rather than spur the competition that will lead to enhanced patient access.
We can be encouraged that the critics have been proven wrong before. When Congress passed Hatch-Waxman in 1984, opponents of the bill predicted that generics would eviscerate research and development incentives, prove to be an unsafe alternative to brands, and that savings estimates were deeply flawed and overstated. The record shows — in all three areas — just the opposite occurred. Today, generics account for nearly 9 out of 10 of the 12 million prescriptions filled daily, and save the U.S. health care system more than $250 billion annually.
We now have three biosimilars approved in the U.S., and others soon will follow. Analysts note that price reductions will increase with more competitors on the market. And the pipelines are thriving; FDA notes that more than 60 biosimilars are in various stages of development.
With smart policies that incentivize competition through the development and use of biosimilars, we can promote greater affordability while also expanding patient access. Industry leaders, Congress and the FDA must work together to get this right. Patients are depending on all of us to do that.
Chester “Chip” Davis Jr. is the president and CEO of the Generic Pharmaceutical Association.
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