Biologic and Biosimilar Misinformation: FDA Drafts Guidance

Regulatory NewsRegulatory News | 03 February 2020 |  By 

Since at least 2018, various industry groups and biopharma companies have highlighted the ways that the truth has been stretched around biosimilars and their reference products, and they have sought help from the US Food and Drug Administration (FDA) in setting the record straight.

FDA on Monday offered some help in the way of a new draft guidance, with eight questions and answers explaining how companies can promote reference or biosimilar products in truthful and non-misleading ways. But the agency did not single out specific violations or point to real world examples of misinformation.

“Although assessment of each promotional presentation involves a fact specific determination, representations or suggestions that create an impression that there are clinically meaningful differences between the reference product and its biosimilar, such as promotional presentations representing or suggesting that a reference product is safer or more effective than its biosimilar product, or that a biosimilar is safer or more effective than its reference product are likely to be false or misleading. Similarly, representations or suggestions that create an impression that a biosimilar is not highly similar to its reference product are likely to be false or misleading,” the 10-page draft guidance says.

Similarly, FDA says that companies claiming that a biosimilar is in general less safe or less effective than the reference product “simply because the biosimilar is licensed for fewer indications than the reference product would be misleading.”

Misleading comments were highlighted by Pfizer in August 2018, when it filed a citizen petition with FDA asking for help to combat comments that leave out important details about what a biosimilar is or that biosimilars work in the same way as reference products.

And Monday’s draft does reiterate that licensed biosimilars have “been found to be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety, purity, and potency.” But the draft also does not discuss considerations unique to promotional materials for interchangeable biosimilars.

Novartis similarly raised issues with FDA in November 2018 about companies that seek “to foster fear and highlight hypothetical yet unproven risks associated with the use of FDA-approved biosimilars.” The Biosimilars Forum and others also sought to extinguish the ideas that biosimilars are somehow inferior products if they are not approved as interchangeable biosimilars, or to explain how the term “non-medical switching” is used “disingenuously to claim that transitioning from an originator to a biosimilar medicine is not safe.”

FDA’s draft also offers two examples of when it would not object to the promotions described, in addition to one example that would be considered misleading.

The misleading example discusses a statement that accurately conveys the reference product’s higher numeric overall response rates observed in a study, but that does not disclose that this difference in response rates was not statistically significant, and which fails to describe the study design or include other appropriate context.

In addition to the draft guidance, FDA and the Federal Trade Commission (FTC) also announced a public workshop on 9 March to discuss biosimilar competition.

The agencies said they will continue to exchange information about best practices to ensure biosimilar developers can gain access to samples of the reference product. The FTC also said it intends to review patent settlement agreements involving biosimilars to prevent antitrust violations.

Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry


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