It seems that everyone wants access to more generic drugs more quickly. Officials heading government health programs, insurers, and pharmacy benefit managers are promoting generic drugs as a safe and effective way to improve patient care while controlling drug expenditures. Consumers eye generics as a way to cope with higher copays for brand-name drugs. Wal-Mart made headlines in October by announcing a set $4 price for many generic products. And, Medicare drug plans are trying to attract seniors by covering generic drugs through the program's confusing "donut hole."
These and other developments are expanding demand for high-quality generic drugs, for additional dosage forms, and for expensive biotechnology therapies (see sidebar, "Generics outpace growth in drug sales"). Members of Congress have introduced legislation laying out a pathway for bringing lower-cost biopharmaceuticals to market. Democratic gains on Capitol Hill now set the stage for the issue to gain more momentum in Congress in the coming year.
At the same time, the push for more generic drugs has complicated the US Food and Drug Administration's challenge of keeping up with a soaring volume of abbreviated new drug applications (ANDAs) and improving policies and programs. The US Department of Health and Human Services Inspector General is investigating the causes of long approval queues and growing backlogs. FDA is looking for more-efficient regulatory approaches as well as expanded resources.
The only rain on this progeneric parade comes from the innovator pharmaceutical industry. Brand-name manufacturers continue to defend patents and to implement strategies to protect markets for lucrative products. Some of these activities draw criticism from healthcare providers and patient advocates, but failure in the generic–innovator patent battles carries severe consequences, as seen in the "Plavix" (clopidogrel) debacle at Bristol-Myers Squibb in recent months. At the same time, pharmaceutical companies are moving more visibly into generic-drug production to reap some of the rewards of this market shift.
Generics outpace growth in drug sales
Manufacturing issues key
While economic forces drive the clamor for generic versions of biologics and other drugs, more efficient and technically advanced analytical and production systems underlie the ability of manufacturers to produce follow-on versions of complex medicines. Demonstrating the comparability of large molecules, inhalants, and topicals requires an understanding of molecular structure, dosage forms, heterogeneity profiles, impurities, and degradation patterns. If companies must repeat much of the innovator's preclinical and clinical testing, they will end up with highly expensive follow-on biopharmaceuticals, many priced just 25% below the innovator products.
Nevertheless, the prospect of any cost savings has been fueling efforts to establish a pathway for developing follow-on versions of biopharmaceuticals. Because the quality of therapies produced from living cell cultures is variable, even politicians recognize that it may not be possible to develop identical or therapeutically equivalent biotechnology generics. But, many manufacturers and policy makers believe that some kind of abbreviated research and development process could yield more affordable biotechnology treatments.
FDA has held meetings about the scientific and technical issues related to developing follow-on protein products, the agency's preferred term, but the legal and political infighting has delayed a long-promised white paper about the relevant regulatory issues. A key point of contention is whether generics firms would have to conduct a full battery of clinical trials to document that a follow-on product has an efficacy and immunogenicity profile similar to that of a reference product. Biotechnology and pharmaceutical companies insist that another manufacturer cannot access proprietary clinical or manufacturing data about biologics and that new legislation is needed to clarify FDA's regulatory authority in this area.
In Washington This Month