Special Reports Archive

Generics expected to hit double-digit growth

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

Pharmacy benefit managers are becoming increasingly adept at leveraging the power of generics to save client healthcare dollars and improve their own standing, reports indicated.

"The opportunity for lowering costs by promoting generics over brands has never been greater, given the unprecedented number of drugs set to lose patent protection over the next few years," noted the "2012 Towers Watson/National Business Group on Health Employer Survey on Purchasing Value in Health Care."

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers. A new report appearing in the Jan. 7 issue of JAMA Internal Medicine highlighted the powerful role played by branded drug advertising on consumer preferences and physicians' prescribing habits, and asserted that many doctors ignore the cost-saving benefits of generic drugs when writing prescriptions by acceding to patients' wishes.

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

Leaders in both the branded and generic drug industries praised the reauthorization last June of PDUFA, the 20-year-old system by which research-based pharmaceutical companies help fund the government's expensive review and testing process for new drug applications.

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.