In December, AbbVie filed a citizen petition on interchangeability. In its citizen petition, AbbVie argued that before a biosimilar can be designated interchangeable, the FDA should:
- Require interchangeability be established in each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label its product for every such condition of use;
- Clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity; and
- Convene a Part 15 Hearing to obtain public input on the topic, and only subsequently issue guidance or regulations that address interchangeability.
On Tuesday, Sandoz filed a response urging the FDA to reject AbbVie’s citizen petition in its entirety. Sandoz argues:
- The rationale and data used as the basis of the citizen petition are limited, misrepresented, and misleading;
- BPCIA does not require the issuance of guidance prior to FDA reviewing and approving biosimilars and interchangeable biologics; and
- A Part 15 Hearing will not provide any new or additional knowledge on this topic that will not be already be captured during the review and comment period following issuance of draft guidance on interchangeability.
Sandoz states that ample scientific evidence supports switching between a biosimilar and its corresponding reference product without, by itself, raising concerns. Sandoz also argues that it is unethical to conduct clinical studies in patients on indications that the applicant does not intend to pursue. Sandoz seeks clarification from the FDA that interchangeability does not represent a higher standard of safety or clinical effectiveness (all biologics approved by the FDA are safe, pure, and potent for their intended use), and that interchangeable biologics and biosimilars must be manufactured to the same quality levels as are applied to originator biologics.
Though Sandoz says it supports the issuance of FDA guidance on interchangeability, it finds AbbVie’s suggestions to be “clearly and unambiguously an attempt to increase the barriers to development of biosimilars and interchangeable biologics that would in turn limit competition to their biologic products on which exclusivity has expired and dossiers for potential biosimilar competitors accepted for review by FDA.”
Stay tuned for further updates and analysis from the Big Molecule Watch.