This article, written by ACI president Steve Pociask, discusses the benefits of biosimilar dugs. These drugs are generic-like versions of lifesaving brand named biopharmaceutical drugs, called biologics. Europe has had biosimilar competition since 2006, but the U.S. has yet to approve a single biosimilar drug for U.S. patients. The article calls on the FDA to accelerate its rulemaking and write […]
Just last week, Swiss drugmaker Novartis AG applied to create the first generic version of a brand named biologic drug for use in the United States. Their drug, a white blood cell stimulant, would be of great benefit to millions of cancer patients spending every last dime on incredibly expensive biologics. Generic versions of name […]
Drugs that compete with brand-name drugs are usually called “generics.” Off-brand products that compete with an especially complex category of drugs called “biologics,” however, are called “biosimilars.” Whereas generics are chemically identical to brand-name drugs, the FDA defines a biosimilar as having a new active ingredient while being highly similar to the reference product and […]
Lower Prices and Greater Access to Life-Saving Drugs Generic drugs have saved over a trillion dollars in healthcare costs between 2002 and 2011 by competing against name brand drugs. Another opportunity now exists to further reduce pharmaceutical drug expenditures involving a growing, but expensive, innovative class of drugs, called biologics. The introduction of their generic-like […]
July 10, 2014 Ms. Margaret A. Hamburg Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Commissioner Hamburg: On behalf of The American Consumer Institute (ACI), a nonprofit educational and research organization, we are writing to raise an issue of critical concern regarding the naming of biosimilar drugs. We […]
Professor Joseph Fuhr Jr., ACI Senior Fellow and professor of Economics at Widener University, will be speaking on the challenges, lessons and opportunities in the marketing of biosimilars in the U.S. at the BioNJ Breakfast Salon in Bridgewater, NJ on June 2, 2011.
Genetic Engineering & Biotechnology News quotes ACI Expert and Weidener University Economics Professor Joseph Fuhr, Jr at the following link. The article notes the expected explosive growth of biosimilar sand follow-on biologics, but nonetheless expects competitors to proceed cautiously.
Dr. Joseph P. Fuhr, Jr., ACI Senior Fellow and professor of Economics at Widener University, presented at CBI’s 6th Summit on Biosimilars and Follow-On Biologics. His presentation “A Prospective Look at the Shape of Biosimilar and Innovator Companies in Five to Ten Years,” was presented on Wednesday, March 30, 2011. His presentation included: An examination of paths […]
Benefits from Biosimilar Competition Erwin A. Blackstone and Joseph P. Fuhr, Jr. (For a printable version of this ConsumerGram with its footnotes, please click here biosimilar2-1) The U.S. is now developing a process for expedited approval of biosimilars. Biopharmaceuticals are far more complex and costly to develop and produce than chemical drugs. Biosimilars […]
Professors Blackstone and Fuhr, both ACI experts, wrote an interesting article on the tradeoff of increased competition vs. increased innovation and the effects on drug prices. The full citation is: Blackstone, Erwin A. and Fuhr, Joseph P., Jr., “Biosimilars and Innovation: An Analysis of the Possibility of Increased Competition in Biopharmaceuticals,” Future Medicinal Chemistry, vol 2, no. […]