Two federal regulatory agencies are teaming up to take on what they call anticompetitive tactics used to undermine the development and adoption of biosimilars.
In a joint statement Monday, the Food and Drug Administration and the Federal Trade Commission said they would seek to deter activities such as manufacturers of novel biologics attempting to prevent the development of biosimilars by withholding samples, as well as statements that attempt to undermine confidence in their safety and efficacy relative to originator products.
“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn said in a statement. “While these therapies are critical for patients, biological products contribute significantly to drug costs as they are often far more complex to develop than other drugs.”
The statement, signed by Hahn and FTC Chairman Joseph Simons, said that public and private insurers in the U.S. spent $125.5 billion on biologics in 2018, citing a report by IQVIA. Currently, there are 26 biosimilars with FDA approval, but not all have been released onto the market due to intellectual property restrictions.
Several biotech drugs, along with pharmaceutical drugs, are expected to have patents expire this year.
The letter stated that the two agencies would work to identify and deter tactics used to keep samples of reference products out of the hands of companies that need them for testing in order to develop and gain approval for a biosimilar. It also said that they would “address false or misleading communications” that were deemed to make false or misleading comparisons between a reference product and a biosimilar that misrepresented the latter’s safety or efficacy, deceived consumers or thwart competition. Meanwhile, patent settlement agreements between reference product and biosimilar manufacturers would be reviewed to ensure they did not run afoul of antitrust laws.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
It’s not the first time the FDA in particular has gone after branded drugmakers for what it calls anticompetitive practices that keep cheaper products off the market. In 2018, then-Commissioner Scott Gottlieb named dozens of companies that he accused of “gaming” the system by preventing generic drug companies from accessing their products so that they could develop their own. Tactics included using restrictive risk evaluation and mitigation strategies – ostensibly meant to protect patient safety – and limited distribution arrangements to keep them out of generic drugmakers’ hands.
Photo: FDA (via Flickr; free of copyright protection)
