Biosimilars: The Grand Experiment

Biosimilars are the grand experiment. If the biosimilar experiment succeeds, competition will lead to lower prices and increase access for patients. However, if biosimilar competition does not advance the result may be price controls. This could decrease the incentive to innovate and lead to fewer new drugs being developed. Biologics are among the highest priced […]

THE HILL: Public Quality Standards for Biologic Drugs Promote Transparency and Competition; Don’t Get Rid of Them

A draft of the Lower Health Care Costs Act circulated by the U.S. Senate’s powerful Health, Education, Labor, and Pensions Committee includes a provision that would drastically change how the U.S. develops standards for the strength, quality, and purity of medicines, particularly cutting-edge biologics and biosimilars. Read this op-ed at The Hill to learn why […]

Regulatory Uncertainty and Industry Practices Force Consumers to Overpay on Biologics

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, […]

Coalition Sends Letter to FDA: Foster Biosimilar Competition and Reduce Costs

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.

Hill’s Congress Blog: Caution–Drug Competition Not Allowed

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 […]

Prescription Drug Competition Means Savings

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 in Forbes: FDA Action Can Save Lives, Money

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.

ACI in the Huffington Post: FDA Delays Will Cost Money and Lives

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 […]

FDA’s Continued Delay Could Cost Lives

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 […]