Biopharmaceuticals are preparations synthesized from living organisms, especially a human or animal protein, such as a hormone or antitoxin that is used as a diagnostic, preventive, or therapeutic agent. If the preparation is the original drug, it can be patented. Most of us have seen TV adverts for patented new wonder drugs such as Humira, […]
A group of 29 nonprofit organizations filed a letter with the FDA calling on them to foster the development of a robust biosimilars market, which would ultimately reduce prescription drug costs and provide patients with access to more affordable therapies. The letter is available online.
About thirty years ago, generic (unbranded) drugs were first approved by the Federal Drug Administration (FDA) for use by patients. These drugs provided competitive alternatives to more expensive name branded pharmaceuticals, and this competition saved consumers $1.68 trillion (not billion) over the last decade, according to the FDA’s Deputy Commissioner. Lower prices from these alternatives […]
REAL CLEAR POLICY: Competition for some of the priciest drugs may soon be coming to a pharmacy near you. The new development has to do with “biologics,” which are drugs produced in living systems such as plant and animal cells or microorganisms. To Continue Reading, visit Real Clear Policy
ACI’s Capitol Hill event, held of December 9, 2014, discussed the importance of speeding market entry to permit biosimilar competition. That competition would give consumers increased access to lower priced medicine, which would lead to better patient outcomes. Watch the event of the event.
Dr. Joseph Fuhr, Jr., professor of Economics and a senior fellow at ACI, wrote a piece on how biosimilar competition could provide wider choice and cheaper access to lifesaving drugs for patients, but the FDA needs to write the rules necessary to permit competitive entry. His piece is available to read and print at Forbes.
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 […]