As we previously reported, AbbVie filed a citizen petition in December, asking the FDA to convene a Part 15 hearing on interchangeability determinations and to tighten the standards for that determination by, for example, requiring that all indications of the reference product be studied prior to granting an interchangeability designation, even if the biosimilar applicant is not seeking approval for each indication. In March, Sandoz filed a response urging the FDA to reject AbbVie’s citizen petition in its entirety.
In a new comment filed earlier this month, the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council (a division of GPhA) similarly ask the FDA to “summarily deny the AbbVie petition” because the petition “seeks to impede the development and approval of interchangeable biological products by asking FDA to impose overly-stringent, standards to establish interchangeability that are neither required by the statutory language nor justified by sound science.” According to GPhA, AbbVie’s petition “is a thinly disguised attempt to subvert these goals by delaying the issuance of FDA guidance on interchangeability, and seeking to impose unrealistic and unnecessary scientific standards on interchangeability determinations.” GPhA argues that “not only will [AbbVie’s proposed system] create significant disincentives to the development of interchangeable biologics but, more importantly, will impair patient access to affordable alternatives to brand name biologics, contrary to Congressional intent.”
GPhA asserts that AbbVie’s request to convene a Part 15 hearing is “a thinly veiled attempt to delay issuance of draft guidance on interchangeability” because holding such a hearing “would unnecessarily delay issuance of guidance on interchangeability until after this meeting so that feedback from the meeting could be considered.” Further, GPhA argues that a public meeting on interchangeability is unnecessary because the FDA already held public meetings in 2010 and 2012 at which it explicitly solicited comments on interchangeability. GPhA states that AbbVie’s contention that interchangeability was not addressed at those meetings “is patently false” and “not credible.”
In response to AbbVie’s position that an interchangeability designation is appropriate only when the biosimilar is shown to be interchangeable with respect to every indication approved for the reference product, GPhA asserts that AbbVie’s position is “flawed” because the BPCIA clearly and explicitly gives the FDA broad discretion to grant interchangeability designations based upon less than all indications or conditions of use for which the reference product is licensed. GPhA argues that AbbVie’s legal argument “cherry-picks an isolated phrase from the BPCIA and its legislative history and imbues it with a meaning that the language cannot support and that is inconsistent with the rest of the statute.” Specifically, GPhA states that “AbbVie mistakenly reads the phrase ‘any given patient’ in isolation to mean ‘any patient population for which the RP is approved[,]’” but “[w]hen read within the context of the entire statute, however, it becomes clear that ‘any given patient’ refers not to the RP’s indications but rather to the indications and patient populations for which the biosimilar applicant is seeking licensure as an interchangeable biological product.” “Congress,” GPhA argues, “intentionally left the exact data requirements for interchangeability broad and open-ended, thereby granting FDA wide discretion to calibrate data requirements on a case-by-case basis based upon the particular biological product under review. Furthermore, GPhA argues that AbbVie’s position also “is inconsistent with sound science” because the “FDA must have broad discretion to make interchangeability determinations on a case-by-case basis in accordance with its scientific expertise and judgment[,]” “enabl[ing] FDA to calibrate relevant testing requirements to the complexity and risks presented by the proposed interchangeable biological product but also allow[ing] FDA to avoid unnecessary and potentially unethical human testing.”
Finally, GPhA argues that AbbVie’s proposal is “inconsistent with the underlying purpose of the BPCIA, which is to encourage the development of lower-cost, safe and effective biosimilars and interchangeable biological products and increase access to such products by patients.” GPhA states that “[u]nder AbbVie’s proposal, however, the testing necessary to demonstrate interchangeability could approach or even exceed that required to obtain approval of a full BLA by incorporating novel standards such as individual rather than population-based analyses and ‘near certainty’ for comparative risk conclusions.” According the GPhA, the intent of AbbVie’s petition seems to be to “erect significant barriers to the development of interchangeable biological products that, as a practical matter, would serve as an effective deterrent to applicants seeking to use this important licensure pathway.”
Stay tuned for further updates and analysis from the Big Molecule Watch.