Fla. bill allows biosimilar, branded substitution
A new bill (HB 365) in Florida’s state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports. The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years. A similar bill (SB 732) is pending in the Florida Senate, according to reports.
According to the Pharmaceutical Care Management Association, Florida is 1-of-10 states where biosimilar legislation is pending. Other states include Arkansas, Colorado, Indiana, Massachusetts, Mississippi, North Dakota, Texas, Virginia and Washington.
Senators push to ban pay-tor-delay deals
WASHINGTON — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.
Reuters reported that Sens. Amy Klo-buchar, D-Minn., and Chuck Grassley, R-Iowa, were sponsoring a bill to ban so-called "pay-for-delay" settlements. Critics of such settlements say they delay patients’ access to cheaper generic drugs, while drug makers say the settlements are often necessary to allow generics to launch ahead of branded drugs’ loss of patent protection, and that delaying generic launch beyond patent expiry would be illegal anyway.
Branded and generic drug makers alike have strongly opposed attempts to ban the patent settlements, saying that requiring cases to go to trial will only further delay the availability of generics. Industry opposition has contributed to the defeat of previous bills to ban them, Reuters noted.
Report: Biosimilars could save $20 billion per year
While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.
A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.
The report, by auditing and finance firm Grant Thornton, argues that regulatory challenges, clinical trials and efficacy tests continue to present a "huge investment outlay." Over the next four years, the report found, branded biologics representing $40 billion in sales will come off patent, not to mention the $20 billion worth of products already off patent.
The Generic Pharmaceutical Association, a trade group representing generic drug makers, said the report "underscores the need for swift and decisive action to make the promise of biosimilar medicines a reality for the millions of American patients in need of lifesaving biologic treatments."
"Even with the most conservative estimates, this report shows that biosimilars hold the potential to save $20 billion annually," GPhA president and CEO Ralph Neas said.