AbbVie Files Citizen Petition with U.S. Food and Drug Administration (FDA) Regarding Product Labeling for BiosimilarsPatient safety is of the utmost concern to AbbVie. AbbVie supports the entry of biosimilars that have been shown, with robust evidence, including clinical trials, to be as safe and efficacious as originator biologic medicines. As biosimilars are introduced in the United States, there is potential for confusion about this new class of medicines. To ensure the safety of patients treated with biologic medicines, including biosimilars, AbbVie has filed a Citizen Petition with the United States Food and Drug Administration (FDA) requesting clear and transparent labeling of all biosimilars approved by the Agency.
AbbVie’s petition requests that product labeling for biosimilar medicines clearly identify the product as a biosimilar and state that a biosimilar is not interchangeable with its originator (reference) biologic (unless FDA has deemed the biosimilar interchangeable). Labeling should also disclose the relevant data supporting the approval of the biosimilar and should distinguish these data from the data that were derived from the originator biologic. Originator biologic medicines have extensive experience in the patient populations for the diseases the medicine is indicated to treat. It is critical that regulators work to ensure patient safety through rigorous review and clear product labeling of biosimilars as these medicines enter the U.S. market.