Biosimilars continue to gain traction in the U.S. as a result of momentum from policymakers, regulators and others in government to drive patient access to this important category of medicine. The latest example came earlier this month with a significant new rule from the Centers for Medicare and Medicaid Services (CMS).
A biosimilar matches the efficacy and safety of an approved biologic (known as the reference medicine) and is able to be brought to market once the reference medicine’s 12-year market exclusivity expires. Biosimilars offer significant value to patients, providers, payers and health care systems by potentially expanding patient access to standard-of-care and innovative medicines while offering direct and indirect cost savings.
{mosads}These new affordable alternatives should be available to more patients, and in a survey of 3,525 U.S. residents conducted by Lots of Online People (LOOP) on behalf of my company Sandoz, 85 percent of Republicans and Democrats say they would use an FDA-approved biosimilar treatment.
While barriers to biosimilar usage in the U.S. still exist despite a decade of use and rapid uptake of recently approved biosimilars in Europe, the healthcare landscape is rapidly changing. In 2017 alone, we’ve seen action from CMS, the Supreme Court of the U.S. and the US Food & Drug Administration (FDA) that will help accelerate development and patient and healthcare provider adoption of biosimilars in our country.
Earlier this month, CMS changed the Medicare Part B reimbursement policy to assign every biologic, reference product and biosimilar, its own unique billing code (effective January 1, 2018) rather than the current shared code approach. Assigning each biosimilar its own unique reimbursement code creates a robust, competitive biologic market which benefits patients. It also lowers the risks associated with developing and marketing these complex medicines.
In late October, the FDA took steps to dispel myths and inform physicians about biosimilars by launching a new educational campaign. The FDA’s new campaign consists of materials highlighting important definitions and explanations of the stringent regulatory process biosimilars must go through in order to be approved, as well as the concepts related to extrapolation and interchangeability.
The importance of this campaign cannot be understated; it shows government dedication to improving access to critical treatments for patients and addresses a large need for physician education surrounding biosimilars. A SERMO poll conducted in October 2016 found that there are still significant knowledge gaps among physicians about biosimilars, including what biosimilars are and how they can be used to increase access to patients and reduce cost. In addition to the SERMO poll, research presented at the American College of Rheumatology meeting this month, found that only 40 percent of rheumatologists surveyed knew that biosimilars match the safety and efficacy of their reference products.
In order for the biosimilar market to expand in the U.S., and bring with it increased treatment access and cost savings, physicians must be aware of and feel comfortable prescribing biosimilars, which is only possible with a greater understanding of their stringent approval process.
In addition to the CMS changes and FDA education campaign, in June of this year, the U.S. Supreme Court provided much needed clarity on how the “patent dance,” a process by which biosimilar manufacturers and reference product sponsors can resolve potential patent risks, will function in Sandoz v. Amgen. The justices also unanimously ruled in favor of Sandoz that notice of commercial marketing can be provided before FDA approval, accelerating patient access to future U.S. biosimilars by 180 days.
New data on switching between biosimilars and reference biologics continues to be published, providing further evidence of the match between biosimilars and their reference products. Final interchangeability guidance, which will provide direction for when a pharmacist can substitute a biologic with a biosimilar without consent of a doctor, is imminent, with the FDA evaluating comments it received from stakeholders in the spring.
Additionally, with a clear regulatory pathway established and the approval of the first U.S. biosimilar following the enactment of the Biologics Price Competition and Innovation Act (BPCIA), Zarxio® in 2015, six biosimilars have been approved in total, including three biosimilars that were approved by the FDA this year alone. This is an important indicator of the agency’s commitment to accelerate acceptance of this new category of medicine.
The tide is turning for biosimilars and more can be done across stakeholders and with increasing endorsement, clarity and support from the government; ever expanding patient access and substantial cost savings are on the horizon.
Sheila Frame is vice president and head of biopharmaceuticals, North America, Sandoz.