GPhA: AbbVie's Petition On US Biosimilars A Ploy To Delay Interchangeables
This article was originally published in SRA
AbbVie Inc's citizen petition calling for a public hearing1 before the US Food and Drug Administration issues its long-awaited biosimilars guidance on interchangebility is nothing more than a "thinly disguised" ploy to block cheaper biologics that may be substituted for the brand-name products, the Generic Pharmaceutical Association (GPhA) and its affiliated Biosimilars Council argued in public comments submitted to the US regulatory agency.
And, they charged, AbbVie's arguments that a biosimilar should not be deemed interchangeable unless the drug was explicitly tested in every indication for which the reference product is licensed are "flawed" and rely on a misinterpreted football analogy and cherry-picked language from the Biologics Price, Competition and Innovation Act (BPCIA) – the law that gave the FDA the authority to approve biosimilars.
Therefore, the groups insisted, the FDA should "summarily deny the AbbVie petition," which the company submitted this past December.
In a twist, AbbVie's tumor necrosis factor blocker Humira (adalimumab) was targeted to be copied as a biosimilar by Amgen Inc., whose own innovator products – Neupogen (filgrastim), Neulasta (pegfilgrastim), Epogen (epoetin alfa) and Enbrel (etanercept) – have been chased by biosimilar makers.
In fact, Sandoz Inc.'s Zarxio (filgrastim-sndz), a version of Neupogen, was the first biosimilar on the US market3. It has not yet sought the interchangeability designation.
Amgen's application for its adalimumab biosimilar is pending before the FDA.
If the FDA were to hold up on its interchangeability guidance until after it's convened a public meeting, it would create an unnecessary delay in getting that document out the door and to manufacturers, GPhA and the Biosimilars Council argued, pointing out the agency already has convened two hearings on implementing the BPCIA – in 2010 and 2012.
AbbVie's assertions those meetings didn't thoroughly address interchangeability is "patently false," the two lobbying groups contended, insisting the FDA "explicitly" solicited feedback at the first meeting on what factors it should consider when determining if a biosimilar could be expected to produce the same clinical result as the reference product in "any given patient" and in evaluating the potential risk related to alternating or switching between an interchangeable and the innovator or among the interchangeables.
The FDA also sought and obtained comments on interchangeability at the 2012 public meeting, where "many presenters" at that hearing spoke about the matter, and the agency also received written comments, so AbbVie's contention "is not credible," GPhA and the Biosimilars Council argued, contending that a third public meeting would be unnecessary and would only serve to delay the entrance into the market of interchangeable biosimilars.
They insisted it's "critical" for the FDA to move forward on the interchangeable guidance as "expeditiously as possible."
"Further delays could have a strong chilling effect on the development of lower-cost, safe and effective interchangeable biologics," they said, mirroring comments submitted last month by biosimilar maker Sandoz.
The trade groups noted there would be plenty of time for stakeholders to provide feedback, given the FDA issues guidances first in draft form and then takes comments before finalizing the documents.
Are You Ready For Some Football?
GPhA and the Biosimilars Council also said the FDA should reject AbbVie's demands to impose a requirement that all indications be explicitly studied before the agency grants an interchangeability designation, which they said was "inconsistent" with the BPCIA.
The trade groups contended the BPCIA granted the FDA "broad discretion" to establish interchangeability requirements on a "case-by-case" basis.
AbbVie's argument that lawmakers meant for the phrase "any given patient" to be interpreted as "all patients" for which the innovator is licensed "imbues it with a meaning" the BPCIA's language "cannot support," GPhA and the Biosimilars Council told the FDA.
AbbVie had likened "any given patient" to the phrase "any given Sunday," coined by former National Football League (NFL) commissioner Bert Bell – meaning on any given Sunday, any team in the NFL could beat any other team.
But GPhA and the Biosimilars Council pointed out the flaw in that argument – the NFL doesn't play year-round. It has a season, although it also has a pre- and a post-season, now, too.
Nonetheless, Bell didn't mean "all" Sundays in the calendar year, just like Congress didn't mean all patients for which the innovator drug was approved, they said.
AbbVie's interpretation of the BPCIA, the groups charged, "violates the bedrock principle of statutory construction that a provision cannot be read in isolation but instead must be interpreted in context, taking into account not only the text itself but also the structure and purpose of the statute as a whole."
When read within the context of the entire statute, they insisted it becomes clear that "any given patient" refers not to the licensed indications for the innovator drug, but for the uses the biosimilar applicant is seeking for its product as an interchangeable biologic.
They also pointed out that lawmakers had in fact considered requiring biosimilar makers seeking interchangeability to study each innovator drug-approved indication under a measure introduced by Representative Anna Eshoo (Democrat-California), but rejected that idea – dropping the language from the final BPCIA bill when Congress passed it in March 2010 as part of the Affordable Care Act.
AbbVie's petition to the FDA, however, ignores that fact, GPhA and the Biosimilars Council asserted.
Not Enough Incentive
GPhA and the Biosimilars Council also argued that the one year maximum exclusivity on commercial marketing for interchangeable was not enough incentive to conduct the extensive clinical testing AbbVie had insisted on in its petition, which the groups said "could be more rigorous and involved" than what is required for a full biologics license application for innovators.
Given that innovators get 12 years of exclusivity protection against biosimilars, "It simply is not rational to suggest that Congress believed it could incentivize extensive clinical research requested with 1/12th of the exclusivity reward," they said.
The one-year maximum interchangeables get, the lobbyists said, is meant to encourage "investment in improved science" – clinical or nonclinical – which could lead to more affordable, high quality products.
References
1. AbbVie Calls For US FDA Hearing On Biosimilars Interchangeability, Scrip Regulatory Affairs, Jan. 1, 2016
2. Comment from Generic Pharmaceutical Association (GPhA) and the Biosimilars Council for Docket No. FDA-2015-P-4935, April 1, 2016, www.regulations.gov/#!documentDetail;D=FDA-2015-P-4935-0004
3. Novartis/Sandoz make US history with 1st biosimilar approval, Scrip Regulatory Affairs, March 9, 2015
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