WASHINGTON, Dec. 9, 2014 /PRNewswire-USNewswire/ — The American Consumer Institute Center for Citizen Research (ACI) today hosted an event on Capitol Hill bringing together a panel of experts highlighting the dramatic benefits that unimpeded biosimilars competition would mean for both patients and taxpayers. The event was held as the Food and Drug Administration (FDA) is working to finalize regulations to create a pathway for biosimilars to come to market in the United States, and these guidelines will have a significant impact on the ability of biosimilars to compete effectively with much more expensive name-brand biologic drugs.
“Like the savings that generic drugs have brought to consumers, there is another opportunity for increasing competition and dramatically reducing pharmaceutical drug costs,” said Stephen Pociask, ACI’s President and the moderator of the event. “This time, it involves a growing, but expensive, innovative class of drugs, called biologics, and the potential of their generic-like counterpart, called biosimilars. “The FDA has not yet created a pathway for biosimilar drugs to enter the U.S. market, even though other countries have approved these lifesaving drugs as far back as 2006.”
Andrew Mulcahy, an associate policy researcher at the RAND Corporation and coauthor of a recent study on biosimilars competition, articulated a summary of his findings. Biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024, his study concluded. “Taxpayers and basically anyone who is buying health insurance would benefit from [biosimilars competition],” Mulcahy said.
Leigh Purvis, Director of AARP’s Health Services Research, spoke of how consumers will benefit from biosimilars competition. The median income among Medicare beneficiaries is about $22,500, while the annual cost of biologic drugs can range from $25,000 to $400,000. And seniors often have to be on more than one biologic drug. With cost sharing, Medicare beneficiaries can be responsible for 20 percent or more of the cost of the drugs.
Purvis also explained AARP’s perspective on International Nonproprietary Names (INNs), a topic on which FDA may soon weigh in. The makers of biologic drugs have asked the FDA to create an entirely unique naming system for biosimilars in the United States that diverges from the existing, effective system for drug naming used around the world. “Different INNs could lead to prescriber and patient confusion and possibly impact patient safety,” Purvis’ slide presentation said. “Different INNs would reduce substitution and subsequent competition, increasing health care costs.”
Jillanne M. Schulte, Director of Regulatory Affairs for the American Pharmacists Association, agreed with Purvis’ view on naming, saying the naming structure should “mirror” that of small molecule drugs. She said a unique naming system would cause confusion between prescribing physicians and pharmacists – confusion that could lead to medication errors. Europe has had biosimilars on the market since 2006 and uses a same-name INN system, with no safety or efficacy issues, she added.
Christine Simmon, Senior Vice President of Policy & Strategic Alliances at the Generic Pharmaceutical Association, said the biologic drug originators request for unique names was a “red herring designed to undermine patients and prescribers’ confidence in biosimilars.”
The American Consumer Institute is a 501(c)(3) nonprofit educational and research institute.
SOURCE: American Consumer Institute