While the FDA already oversees biologic and biosimilar drug marketing, the agency, along with the Federal Trade Commission, recently reinforced a commitment to address misleading promotions and anti-competitive practices.
The two agencies released a joint statement detailing their promise to police promotional messaging as well as review patent agreements to prevent antitrust collations, share best practices and collaborate on public outreach. To the latter goal, they announced a public workshop on the “Competitive Marketplace for Biosimilars” on March 9 at FDA headquarters.
“Given biosimilars are relatively new territory, FDA is making sure it puts up the markers of the lanes very clearly as more come to market. It achieves the policy goal of supporting the market by seeking to reinforce clarity in the market and uptake of less expensive meds,” Mark Senak, a lawyer and PR professional with expertise in regulatory communications and medical products, said in an email.
In the issued statement, the FDA also announced new draft guidance on which it will take submitted comments through April 2. The “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers” filing is meant for manufacturers, packers, distributors and their reps to use when creating promotional labeling and ads for biosimilar products and reference materials.
The draft includes direction on how biosimilars makers should handle the use of reference names—the original biologic brand—in marketing materials. It notes that companies should be careful when using a reference product and a biosimilar product and should avoid suggesting that a biosimilar product is not highly similar to a reference product or that there are clinically meaningful differences.
For instance, a biosimilar drug could be touted as just as effective as its reference drug, but its maker couldn’t claim that it works better.
While the rules for biosimilars are, well, similar to the rules the FDA uses to police all marketing, the newness of the emerging market and the difference between biosimilars and generic drugs (which are exact copies; biosimilars are not) likely inspired the proposal.
“I think the FDA/FTC announcement is meant to highlight that this is an area that is going to be looked at carefully and sends a signal that while such practices are already addressed, there is radar up that is examining promotional communications that may be in violation,” Senak said.