Senators push for 12-year exclusivity model for biosimilars
WASHINGTON As the House and Senate fuse their respective healthcare-reform bills into one, a push has been made to ensure that the final law contains language for knockoffs of biotech drugs.
In a letter to Senate majority leader Harry Reid dated Jan. 13, eight Democratic senators asked that the law preserve a regulatory approval pathway for biosimilars with a 12-year data exclusivity period.
“The pathways for the approval of biosimilars included in both the House and the Senate bills will reduce drug costs for millions of Americans while ensuring continued research and development into innovative biologics which will improve countless lives,” read the letter, signed by Sens. Kay Hagan, North Carolina, Barbara Mikulski, Maryland, Thomas Carper, Delaware, Jack Reed, Rhode Island, John Kerry and Paul Kirk, both of Massachusetts, and Barbara Boxer and Dianne Feinstein of California.
Should the legislation pass with the biosimilars language intact, it will likely put an end to the five-year exclusivity model for which the generic drug industry has long hoped. Under the Hatch-Waxman Act of 1984, which created a regulatory approval pathway for generic drugs, the Food and Drug Administration must wait five years before using a branded drug manufacturer’s clinical trial data to approve a generic, a period known as data exclusivity. The biotechnology industry has maintained that due to the enormous development costs and high probability of failure, it takes developers of biotech drugs a lot longer to break even on new products than it does for pharmaceutical companies. Meanwhile, the generic drug industry says that long exclusivity periods are a ploy used to keep alternatives to expensive biologics off the market for as long as possible.
Publix joins H1N1 efforts during National Influenza Vaccination Week
LAKELAND, Fla. To coincide with National Influenza Vaccination Week, Publix Pharmacies announced Wednesday an inoculation offer of the H1N1 vaccine for $10. The special pricing for the vaccine will remain in effect until the vaccine supply is depleted. Customers do not need an appointment for the vaccination, but are encouraged to call their local Publix Pharmacy to ensure an immunizing pharmacist is on duty and vaccine supply still is available.
In addition, every customer who receives an H1N1 vaccine from a Publix Pharmacy will also receive a coupon good for a $10 Publix gift card with a new or transferred prescription.
“While influenza is unpredictable, we know that if more people are vaccinated, the disease is less likely to spread in the upcoming months,” stated Maria Brous, Publix media and community relations director. “Our Publix Pharmacists are committed to the total health and wellness of our customers and their families.”
FDA finds Spiriva does not raise risk of heart attack, stroke
ROCKVILLE, Md. Data from a recent review of a treatment for chronic obstructive pulmonary disease do not support allegations that it raises the risk of stroke, heart attack or death, the Food and Drug Administration announced Thursday.
The FDA reviewed a 5,992-patient study of the Spiriva HandiHaler (tiotropium), made by Pfizer and Boehringer Ingelheim as a treatment for COPD, a disease that includes emphysema and chronic bronchitis.
In March 2008, an FDA Early Communication described data submitted by one of the companies suggesting a small increased risk of stroke in patients who had taken the inhaler’s active ingredient. An update in October of that year highlighted two additional publications suggesting an increased risk of stroke, heart attack and death in patients using the drug.