Battle over biosimilars
More research on the quality and safety of generic drugs should support the future development of generic versions of large
molecules, an important goal of the generic-drug industry. New legislation is expected to establish a pathway for FDA to approve
follow-on or similar versions of biological therapies. The regulatory framework for follow-on biologics is not expected to
be the same as that established under Hatch-Waxman for conventional drugs, but the debate continues over how much clinical
research should be required to document similarity between an innovator and a follow-on product, and over how much exclusivity
brand manufacturers should be granted to stimulate new research and development.
Healthcare-reform legislation moving through Congress proposes 12 years of market exclusivity for innovative therapies, a
term championed by pharmaceutical and biotechnology companies, but hotly opposed by generic-drug firms as likely to block
biosimilar development. A long exclusivity period, said Marth, "will result in few, if any, generic biologics and less, rather
than more, innovation." Teva would be involved in this market, he predicted, but as an innovator firm.
Almost as contentious as the exclusivity issue is what kind of framework will be established for resolving patent disputes.
Proposals differ for requiring the disclosure of patent information, for challenging patent terms, and for communicating pending
challenges to the involved parties. Generic-drug makers won a small victory by gaining Senate approval of an amendment to
assign the same Medicare billing code to brand and follow-on products, an approach that would encourage the use of biosimilars.
But this policy has much less of an impact on research and development decisions than the data-exclusivity term does.
Carve-outs and settlements
While seeking political support for follow-on biologics, generic-drug manufacturers also have gone on the defense to oppose
policies designed to reduce generic-drug use. One threat comes from state "carve-out" laws, policies that limit the ability
of pharmacists to substitute a generic product for a brand prescription. Such approaches reflect fears that certain drugs
raise safety and substitutability concerns and require special attention by prescribers and additional protections for patients.
Generic-drug makers also oppose efforts by brand-name manufacturers to market authorized generic products just before patent
expiration to delay generic competition during the 180-day exclusivity period. The looming wave of patent expirations is prompting
the development of more branded generics by pharmaceutical companies. These drugs are produced either by the original manufacturer
or under contract by a generics maker. Major pharmaceutical manufacturers are purchasing generics firms around the world to
become more prominent in generic-drug marketing.
Interestingly enough, both innovators and generic-drug companies want the flexibility to settle patent disputes through agreements
involving pharmaceutical payments to generic-drug firms to delay market entry until an agreed-on future time. The Federal
Trade Commission (FTC) and other critics have labeled these pay-for-delay deals as anticompetitive, but manufacturers on both
sides claim that such arrangements can avoid lengthy patent battles and end up accelerating consumer access to generic products.
FTC has gone to court to block several delay settlements, and Congressional leaders seek to impose curbs on such deals.
One benefit of the generic-drug industry's growth has been expanded access to high-quality, low-cost medicines around the
world. Federal government efforts to ramp up the distribution of treatments for HIV and AIDS in Africa and other developing
areas initially faced a dilemma. The most effective brand-name combination AIDS therapies were expensive and would quickly
eat up program funds, but policymakers considered it unethical to purchase less effective old-line generics or products that
might be counterfeit or adulterated.
The solution was to establish an FDA program that grants tentative approval to generic versions of patented AIDS therapies
for distribution overseas. During the past five years, consequently, FDA has approved more than 100 generic drugs for the
President's Emergency Program for AIDS Relief (PEPFAR), including 71 generic versions of antiretrovirals that are marketed
in the US and not yet eligible for generic competition because of patents and exclusivity. Permitting PEPFAR to access these
less costly, high-quality products saves the program $150 million per year, commented FDA Commissioner Margaret Hamburg, and
thus increases the amount of quality products PEPFAR can make available to treat people around the world.
The policy also demonstrates that there is "no double standard for the US and the rest of the world," commented OGD director
Buehler. "It is something that the generic industry should be proud of."
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, email@example.com