Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. Biosimilars now have the potential to create substantial savings on complex biologic drugs, but only if we can remove the unnecessary barriers that stall their approval and adoption.
In 2015, our company, Sandoz, a division of Novartis, received Food and Drug Administration approval for the first biosimilar in the U.S. Called Zarxio, it is a biosimilar of Amgen’s Neupogen (filgrastim), which is used to help the body make more infection-fighting white blood cells.
At the time, many in health care hoped this represented the beginning of widespread adoption of biosimilar versions of biologic medicines after their patents expired, creating significant benefits for patients and cost savings for the U.S. health care system.
As we write this, the FDA has approved a total of 17 biosimilars. So far, though, Zarxio is the only one to have become commercially successful in the U.S. According to data from IMS Health (now IQVIA), uptake of other biosimilars has been limited. This stands in stark contrast to how these medicines have fared in many other countries, where biosimilars are widely accepted, broadly used, create substantial savings for health care systems, and expand access for patients.
Last year, Zarxio became the first biosimilar in the U.S. to surpass its reference biologic medicine, accounting for more than 45 percent of the units of short-acting filgrastim dispensed. This milestone, and the fact that biosimilar competition in the filgrastim market has already saved the U.S. health care system approximately $500 million in less than two years, shows that biosimilars have the potential to be successful in the U.S. even with existing barriers to their use.
Recent efforts to streamline the regulatory process, such as the FDA’s Biosimilars Action Plan, are steps in the right direction. But they aren’t enough to ensure that these medicines reach patients. We need a multipronged approach to improve post-approval uptake that includes expanding educational programs and encouraging good-faith efforts to efficiently and fairly resolve patent disputes.
Better education for physicians and patients
An essential factor for increasing biosimilar adoption is broadening awareness of their value. Despite clinical and real-world evidence showing that patients can safely switch from brand biologics to biosimilars without sacrificing any therapeutic benefit, many physicians remain hesitant to switch. Industry, advocacy organizations, and government groups need to overcome this barrier by providing guidance and facilitating educational opportunities. They can also partner to create and share content that can help dispel misinformation and provide knowledge and clarity for a variety of audiences.
Both the European Medicines Agency and the United Kingdom’s National Health Service have created educational materials to help physicians educate their patients on biosimilars. This endorsement of the importance of these medicines must be duplicated in the U.S. to complement the FDA’s ongoing biosimilar education programs, which the agency has said it intends to increase.
When it comes to addressing skepticism surrounding biosimilar medicines, no better educational resource exists than real-world evidence. A nearly 13-year body of real-world evidence in Europe shows that the availability of biosimilar medicines has expanded patient access to biologic medicines while delivering the same safety, effectiveness, and quality of care. The biopharmaceutical industry commits substantial time and resources to gathering these critical data points, which demonstrate how a therapy works in actual practice.
As the FDA has initiated educational activities, so too should groups such as professional societies, patient advocacy organizations, and manufacturers. We must collaborate to equip physicians with the resources to have productive conversations with their patients in language that is understandable for all.
Speed resolution of biosimilar patent disputes
Another major reason for the slower uptake of biosimilars in the U.S. is that it did not provide a pathway for biosimilar approval until 2010 (four years after biosimilars were approved in Europe) when the Biologics Price Competition and Innovation Act was enacted. This act includes a procedure for resolving patent disputes concerning biosimilar medicines as early as four years into the 12-year period of market exclusivity that applies to biologic reference products.
Unfortunately, these early opportunities for resolution have not been available for the first generation of U.S. biosimilar products — which includes all biosimilar medicines approved and pending today — because the market exclusivity period did not apply to biologic reference products that were already on the market when the biologics act came into effect. As a result, litigation for this first wave of biosimilars has, in many cases, extended beyond the FDA approval date for the biosimilar.
For future biosimilar medicines, companies should be able to initiate patent challenges far earlier in the approval process — up to eight years before launch, as established in the Biologics Price Competition and Innovation Act — which is one way of potentially speeding access for biosimilars. In the meantime, though, all participants in biosimilar patent litigation, including the courts themselves, should strive for speedy resolution of these disputes to enable faster launches when patent challenges are successful.
Administrative alternatives to litigation such as inter partes review and post grant review can also help more quickly resolve even these first-generation biosimilar disputes, and should remain available for biologic medicines at all stages of development.
There is still work to be done in the U.S.
The time is now for insurers, health care providers, patients, regulators, policymakers, professional organizations, and industry to come together and take practical steps to speed the adoption of biosimilars. Biosimilars have already created significant cost savings for patients and health care systems in the U.S., and the introduction of other biosimilars here can further expand access, improving outcomes for patients battling debilitating and potentially life-threatening diseases.
Biologic medicines that represent approximately $100 billion in sales are expected to be off patent by the year 2020. That represents a substantial opportunity for biosimilar medicines to create savings for the U.S. health care system. The question is, will we be able to act sooner rather than later to make a difference for patients today?
Carlos Sattler, M.D., is head of clinical development and medical affairs at Sandoz. Sheila Frame is vice president and head of biopharmaceuticals, North America, at Sandoz.