Future of generic biologics highlights GPhA conference

WASHINGTON —The Generic Pharmaceutical Association recently held its third annual policy conference to discuss the present and future state of generic pharmaceuticals in terms of business, law and product development. The conference, which took place here, featured such speakers as Janet Woodcock and Sheldon Bradshaw of the Food and Drug Administration, U.S. Representative Henry Waxman, D-Calif., and pharmaceutical company chief executive officers Robert Wessman of Actavis and Robert Coury of Mylan.

Starting off the convention was GPhA president and chief executive officer Kathleen Jaeger who dove right into the issues of biogeneric legislation and generic drug availability for consumers. She said that, “For the countless Americans who are in need of safe and affordable life-saving biogenerics, it is imperative that Congress continue to move legislation forward. That’s why we were encouraged to hear from key members of Congress and their staffs today that they are totally committed to passing legislation. We’ve come a long way in a short period of time, but we still need to cross the finish line. More than 70 diverse organizations have asked Congress to put patients first by making affordable life-saving medicines available. We cannot let patients take a back seat to profits.”

Waxman talked about the future of generic drugs and the role biologics will play. Biologics, genetically engineered drugs that are used in non-human cell cultures to produce drugs, have been on the market for more than a decade, but generic versions of these drugs are nowhere to be found.

Waxman called out brand companies who are more focused on delaying generic approvals than researching new drugs. “Brand name companies spend more money delaying generic company approvals than spending on new drugs,” according to Waxman.

He also talked about brand manufacturers using citizen petitions to again delay cheaper generic medications from reaching consumers’ hands. Upon receipt of these petitions, the FDA typically delays abbreviated new drug application approvals until the issue underlying the citizen petition is thoroughly resolved, resulting in generic market entry delays of months, if not years.

Taking a look at the business aspect of the generic pharmaceutical industry was guest speaker Doug Long, vice president of industry relations for IMS Health.

In the United States so far this year, prescriptions dispensed have increased by 4.4 percent, with generic drugs gaining ground in total sales. According to IMS, generic sales have grown faster than brands for the last five years. In the last two years, unbranded generics have significantly outpaced branded drugs. In 2006 unbranded generics grew more than 20 percent whereas brands grew less than 10 percent, according to IMS.

Of the top 20 companies according to sales, three are generic companies, the highest ranked being Novartis at No. 7 with a 5.1 percent of the U.S. market and $14.4 billion in sales. Pfizer landed the No. 1 spot with $25 billion in sales and 8.9 percent of the market.

The future according to Long is based on Medicare Part D playing a more active role in the generic drug industry, as plans offer better co-pays to consumers for lower-cost generics. As for the drugs themselves, IMS reports $12 billion worth of medications are losing patents in 2007 with another $20 billion losing protection in 2008.

Wessman was a headliner at day two of the conference when pharmaceutical companies got a chance to contribute to the discussion on generics. Under Wessman, Actavis has grown into a billion-dollar company and a major player in the generics game in less than a decade.

Wessman believes the pipeline is crucial for the future of generics and sees a “greater need to develop new dosage forms, including control-release, transdermals and sustained-release products.” Currently, the company has 50 control-release products in development for the United States. The pipeline for the company consists of 377 products, which includes 277 development projects and molecules and 100 ongoing registrations. The company sees itself fighting in the future to become and stay one of the top five players in each market around the world.

Generic drugs have a chance to boom over the next five years, thanks to patent expirations occurring on brand-name drugs. As for biologics, if the government can work to help generic companies get their products on the market, the generic industry will continue to see significant double-digit increases.