An increasingly visible generic-brand battleground involves the details governing future generic versions of biotech therapies.
Product "naming" remains a contentious issue, as biotech firms press for unique names on biosimilars to differentiate them
from the innovator product. The companies claim that clear product identification is needed for accurate adverse event reporting
and quality oversight. However, unique names also could discourage future product substitution if FDA deems the biosimilar
interchangeable. Biotech manufacturers claim that no biosimilar will ever be the "same" as the reference product, and that
interchangeability will not be feasible. But just to make sure, industry is pressing state legislatures to revise pharmacy
laws to make it even more difficult for pharmacists to substitute a biosimilar for a brand.
The issue made headlines recently as the California legislature approved a bill that requires pharmacists to notify the prescribing
doctor of a biosimilar substitution. Such legislation has been adopted in North Dakota and three other states, but most have
sunset provisions that could limit their impact. Similar bills have died in 10 other states, but innovator firms continue
to press for action across the country.
Jim Greenwood, president of the Biotech Industry Organization (BIO), claims that the California bill is necessary to safeguard
the patients' right to know what treatments they receive, and that even very minor differences in production of a biologic
can have an impact on individual response. Notification thus enables physicians to be aware of the precise course of treatment
given any patient and, BIO says, is key to permitting future substitution of interchangeable biologics.
The Generic Pharmaceutical Association (GPhA) counters that notification requirements really aim to paint biosimilars as different
and unsafe. The California Public Employees' Retirement System opposed the measure as likely to restrict consumer access to
lower-cost biosimilars, and the Academy of Managed Care Pharmacy urged California's governor Jerry Brown to veto the bill
for similar reasons.
FDA weighed in by noting that the agency has set high standards for approving an interchangeable biological product and that
efforts to "undermine trust in these products are worrisome and represent a disservice to patients who could benefit from
these lower cost treatments." With biologics predicted to account for eight of the top 10 drugs by 2016, the stakes are high.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at email@example.com