Even though BPCI provides 12 years' exclusivity for innovator biologics, a period when FDA cannot approve a product based
on innovator data, the subject is far from settled. Innovators also gain a four-year delay following reference-product licensure
during which time biosimilars sponsors cannot submit a 351(k) application. Biotech companies consider these protections crucial
for encouraging investment in research and development. Critics, however, claim that 12 years exclusivity is too long, and
the Obama administration recently proposed reducing exclusivity to 7 years.
The shorter protection period also aims to minimize exclusivity "evergreening," which refers to the practice of manufacturers
seeking an additional period of protection for products that are modified enough to qualify as new. FDA has to define what
changes would sufficiently affect a product's safety, purity, or potency to warrant extended exclusivity. The change has to
be significant, says Kozlowski of CDER. "I don't think that 'slightly better purity' is enough to extend exclusivity," he
observed at the DIA/FDLI conference.
As with conventional generic drugs, patent and exclusivity issues involving biosimilars are likely to generate extensive regulatory
maneuvering and lengthy court battles. Manufacturers on both sides of the market are expected to file citizens' petitions
challenging FDA's interpretation of BPCI, particularly regarding how it defines "biosimilar" and what constitutes "interchangeability."
The legislation establishes an even more complex system for dealing with patent and regulatory disputes than applies to conventional
generic drugs. Unlike the Hatch–Waxman Act, the BPCI doesn't directly involve FDA in listing patents. Instead, the law requires
biosimilars developers to provide reference-product makers with a full dossier on its process and product so that the innovator
can identify those patents it feels may be infringed. This "hokey-pokey process," explained Sidley Austin Attorney Jeffrey
Kushan, was designed to promote early agreement on those patents worth fighting about. But Kushan fears it will create a more
complicated litigation process involving multiple deadlines and requirements that will please no one. Biosimilars makers complain
that too many parties will see their confidential regulatory filings, while BLA-holders stand to lose protection if they fail
to follow all the rules. If the 351(k) process becomes too contentious and costly as a result, biosimilars sponsors may opt
to follow the traditional BLA route to market—and the reward of 12 years exclusivity.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org