On the whole, the FDA’s plan, says Robert Cerwinski, JD, is “net good news for the biosimilar developers,” and should provide “tailwinds” for the industry by giving greater clarity, streamlining processes, and reducing the time and expense that biosimilar developers will need to bring their products to the marketplace.
When the FDA Commissioner Scott Gottlieb, MD, last week unveiled the FDA’s Biosimilar Action Plan, many of the document’s features centered around actions already taken by the FDA or reiterating promises to release expected deliverables. However, according to Robert Cerwinski, JD, a partner at Goodwin who focuses on litigation involving pharmaceuticals and biologics, some novel elements of the plan are cause for strong interest.
First, Cerwinski told The Center for Biosimilars® in an interview, is the fact that the FDA is working on guidance that will provide clarity on “label carveouts,” or approval for fewer than all of the indications for which a reference product is approved. In cases in which some of the indications of a reference product are covered by a patent while others are not, current guidance is unclear as to how a biosimilar product sponsor can seek approval for a portion of the drug label in a manner similar to the way in which a generic product sponsor might.
“The machinery for doing that and the law that permits that is fairly well developed in the generic world,” explained Cerwinski, and given that providing the option for label carveouts has proven to be a useful way to reduce barriers to market entry, “It’s very interesting that Commissioner Gottlieb and his staff have picked up on that and are trying to give biosimilar applicants some more clarity,” he said.
If a biosimilar were approved for an indication not covered by a patent, the biosimilar could potentially launch in that indication sooner than it would if it gained approval in all indications of the reference product. That is a possibility that could raise concerns among innovator product sponsors about a biosimilar being prescribed for off-label indications. However, “it’s unclear the extent to which a biosimilar would be prescribed for off-label uses,” said Cerwinski.
What is clear is that for biosimilar product developers, anticipated label carveouts should help companies determine their overall litigation strategies; planning well in advance which indications should be challenged through the inter partes review process will be key and could potentially streamline the Biologics Price Competition and Innovation Act litigation process.
The second feature of the plan that Cerwinski found notable is that the FDA appears to be “a little bit more activist” in terms of working with other agencies, such as the Federal Trade Commission (FTC), to remove barriers to biosimilar market entry that are not within the FDA’s purview—including cracking down on rebates provided by drug manufacturers. “In the past, FDA has not always wanted to weigh in to such disputes,” he said.
Finally, a feature of the plan that notes that the FDA is exploring the possibility of allowing the use of non—US-licensed comparator products in clinical programs that support a biosimilar application could have an impact upon yet another newly announced action of the FDA: considering the importation of drugs in cases of supply issues.
“I see no reason why, in a case of a true supply constraint, it would matter whether it was a biosimilar or a small molecule drug” that would be considered for importation, said Cerwinski. However, if a biosimilar considered for importation was approved with respect to a foreign-licensed reference product, “What sort of bridges into the US approval process can the biosimilar applicant take advantage of to make sure that the clinical trials they spend their money on abroad give them some benefit in the approval process the [United States]?” The potential for approval of biosimilars using foreign-licensed comparators could bring some clarity to that question, and to the question of which drugs could potentially be imported for US use.
On the whole, the FDA’s plan, says Cerwinski, is “net good news for the biosimilar developers,” and should provide “tailwinds” for the industry by giving greater clarity, streamlining processes, and reducing the time and expense that biosimilar developers will need to bring their products to the marketplace.