FDA and Manufacturers Ponder Biosimilars Pathway - Follow-on versions of complex biologics require extensive expertise. - BioPharm International


FDA and Manufacturers Ponder Biosimilars Pathway
Follow-on versions of complex biologics require extensive expertise.

BioPharm International
Volume 24, Issue 7, pp. 12-14


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,

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