A recent white paper from the Association for Accessible Medicines (AAM) highlighted the continued need to lower prescription drug prices. According to the paper, up to half of all patients fail to adhere to their medication regimen, which is due in part to high drug costs. This, in turn, “is considered responsible for approximately 125,000 deaths, at least [10%] of hospitalizations, and a substantial increase in morbidity and mortality annually.”
The paper goes on to emphasize that, in addition to creating thousands of new jobs, generic competition “continues to play a vital role in improving access to pharmaceuticals and driving cost savings to American patients.” Patients in the brand name biologics market would stand to benefit disproportionately from alternatives, AAM observes. Experts suggest that there is “more than $100 billion in annual spending on biologics in the United States alone,” and that “FDA-approved biosimilars could save as much as $250 billion over the next 10 years.” AAM also notes that patient access to treatment in Europe has increased by up to 100% since 2007, when biosimilars became available. According to an IQvia study cited by the paper, drug patent expiries are expected to increase by 50% over the next five years, which will create greater opportunities to facilitate biosimilar and generic competition.
AAM therefore contends that access to biosimilars should be promoted more aggressively in the coming years, and in particular, that biosimilars manufacturers require greater certainty that their products will be able to enter the market once produced. The paper identified excessive regulation and “patent gamesmanship” by brand name manufacturers as contributing to stalled or abandoned market entry for biosimilars. It suggested streamlining the regulatory approval process for biosimilars to increase predictability and reduce costs. It also urged Congress to enact the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, introduced in 2017, to provide biosimilar drug developers recourse when a biologics licensee fails to make enough samples available for testing, noting that to date, the FDA has received more than 150 complaints about inadequate access to samples. In short, AAM emphasized the need for biosimilars to be placed on a “level playing field” through drug policy. It said, however, “there have been a number of positive developments, in particular establishing independent coding and reimbursement in outpatient settings and putting biosimilars on equal footing with their brand counterparts in Medicare Part D.”
In an accompanying press release, AAM President and CEO, Chip Davis, concluded that ‘[u]nless policymakers take steps to address these challenges, the risk of shortages among generic drugs is likely to increase further, threatening patient health.’