In the States
Select a state to learn more
State Activity
SB 197 / H 195
2015-2016 Session: Convene: 1/14/15 and Adjourn: 7/1/16
Read the letter of support for SB 197 here.
5/14/15: The bill was officially reported and sent to the Governor.
5/12/15: Senate Committee on Health Care reported the bill favorably
4/9/15: Senate has referred the version of the bill previously passed by the House to the Senate Committee on Health Care.
3/9/15: Referred to Senate Committee on Health Care
4/1/15: House Committee on Health favorably reported substitute on H195. House passed the bill on its 3rd reading.
The News & Observer: NC House OKs cheaper ‘biosimilar’ drugs
The N.C. House voted 101-6 on Thursday to approve the use of “biosimilars,” a form of cheaper substitutes for costly medications.
House Bill 195 would require pharmacists to inform patients and doctors when they receive a biosimilar. The drugs are essentially generic alternatives to biologics, a classification of medicine derived from biological sources and used to treat serious illnesses such as cancer and autoimmune diseases.
Read full article here.
-
Bill Information
Amends the generic drug substitution law.
Defines an “interchangeable biological product” as a biological product determined to be interchangeable by FDA or a product that has been deemed therapeutically equivalent by FDA.
Permits the dispensing of an interchangeable biological product in place of a prescribed biologic, provided that:
—the manufacturer’s name and logo is on the label and the drug is manufactured according to GMPs;
—the manufacturer has provisions for drug recall and the return of drugs (not clear whether applies to biologics);
—prescriber does not indicate that substitution is prohibited;
—pharmacist notifies prescriber within 10 days, electronically if possible (and by other means if not), except when there is no FDA-approved interchangeable biosimilar or the prescription is a refill that is unchanged from the prior filling; and
—the price of the interchangeable biologic is lower than that of the prescribed biologic.
Directs the Board of Pharmacy to maintain a link on its site to the current list of FDA-approved interchangeable biologics.
Establishes that a pharmacist who substitutes a biosimilar is not subject to greater liability than would be incurred in filling the biologic prescription.
-
Archive
March 2013 Newsletter
March 27, 2013
State Activity More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed […]
March 2013 Newsletter
March 27, 2013
State Activity More than 15 state legislatures have introduced legislation on substitution over the past few months and ASBM and our members have been very active sending letters of support, testifying at hearings and briefing state legislators on the issue of interchangeability and the need for physician notification. Virginia and North Dakota have both signed […]
NCBIO Emerging Companies Forum
July 13, 2011
November 15, 2011 North Carolina Biotechnology Center Durham, NC Read More
NCBIO Emerging Companies Forum
July 13, 2011
November 15, 2011 North Carolina Biotechnology Center Durham, NC Read More
NCBIO Annual Meeting
July 13, 2011
October 12, 2011 North Carolina Biotechnology Center Durham, NC Read More
NCBIO Annual Meeting
July 13, 2011
October 12, 2011 North Carolina Biotechnology Center Durham, NC Read More
NCBIO Biotech Manufacturers Forum Meeting
July 13, 2011
September 14, 2011 North Carolina Biotechnology Center Durham, NC Read More
NCBIO Biotech Manufacturers Forum Meeting
July 13, 2011
September 14, 2011 North Carolina Biotechnology Center Durham, NC Read More
CED Biotech Forum
July 13, 2011
August 24, 2011 North Carolina Biotechnology Center Durham, NC Read More
July 13, 2011
North Carolina Biotechnology Center North Carolina Biosciences Organization North Carolina Business and Growth Council (BIG) North Carolina Department of Health and Human Services North Carolina General Assembly North Carolina House of Representatives North Carolina Medical Association North Carolina Research Triangle Park North Carolina State Senate NC Bioimpact Office of Governor Bev Perdue
