As pharmaceutical drugs become increasingly complex, industry leaders, from drug manufacturers to representatives from the American Association of Retired Persons, continue to debate whether replicating the drugs is feasible. The debate over biogeneric copies of drugs was the focus of the Global Healthcare Conference held at the Tuck School of Business on Friday.
Biogenerics involves the replication of branded "biologic" drugs -- genetically engineered proteins that are more complex than most drugs on the market. Biologic drugs are used to treat diseases such as rheumatoid arthritis and certain forms of cancer.
Generic versions of simpler drugs already exist, and they are sold for less money than their branded counterparts. Because of their complexity, however, biologic drugs are more difficult to replicate, according to Herman Sanchez Tu'04, who works for a health care company in Boston.
"If you wanted to come up with another Tylenol, you wouldn't have to do a big clinical trial to bring it to market," he said. "There really isn't an equivalent way to get to market for much more complex drugs."
At the conference, advocates for patients' rights argued that the complex biologic drugs produced by biotechnology companies are too expensive for many patients to afford. John Turco, Dartmouth's director of Health Services, said that he deals with two groups of patients in his work -- those who can afford the right medicine and those who cannot.
Biotech firms claim that lowering the cost of the drugs too early after production decreases researchers' incentives to innovate. The high costs of manufacturing biologic proteins will force biogeneric companies to keep drug prices high, according to panelist James Greenwood, president and CEO of Biotechnology Industry Organization.
"One thing the industry will say is that cost savings are not as significant here," said Lisa Miller, one of the organizers of the conference and associate director of the Center for International Business at Tuck. "If you reverse an antibiotic it's pretty easy to do, but the biological molecule is much more difficult."
AARP representative Anna Howard, however, argued that even slight reductions in the cost would greatly benefit consumers.
"The AARP is saying, 'Look if you're paying $20,000 for a drug, even 10 percent savings is good,'" Miller said. "That could be the difference between paying your heating bill and not."
Biotechnology companies also argue that biologic drugs are unsafe to replicate because they are so complicated to manufacture, Sanchez said. Biogenerics companies are generally unwilling to devote an adequate amount of money to ensure safety, he added, referring to information that biotechnology firm Biogen displayed during the conference.
"The whole thing that makes generics worthwhile is that it's cheap and easy to enter the market," Sanchez said. "Biogen had an interesting argument -- they showed that there are countries with less regulation and [biogeneric] products are getting to market and they were able to show really good data that the biogeneric drugs were just not as effective."
In fact, the replicated drugs actually caused patients to produce antibodies that worked to counter the biologic drug's therapeutic effects, according to the Biogen representative, making them dangerous for patients.
The conference allowed the audience to hear a wide range of perspectives, Miller said.
"We had a lot of people with tremendous expertise on the topic, but we had a lot of opposing viewpoints," Miller said. "Are you really going to be able to make biogeneric drugs that are as safe and as effective as the original drug, and if you can't is it really worth it?"
