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State Activity
The Alliance for Safe Biologic Medicines was organized to serve as an authoritative resource center of information for the general public, as well as the healthcare and health policy communities, on the issues surrounding biologic medications.
Each state will be considering or introducing legislation to address what an FDA determination on interchangeability will mean for state substitution policies. While the ultimate goal is to find a balance between producing economical drugs and respecting the drug-discovery process, patient safety should be paramount.
We are particularly concerned about how state laws and regulations will impact the doctor-patient relationship. Doctors and patients should be able to carefully choose the best course of treatment rather than have legislators and regulators decide for them. The path state governments decide to pursue in approving biosimilars should reinforce this principle.
As such, a number of local organizations have joined together to ensure that state biosimilar interchangeability and substitution issues are not implemented in ways that negatively impact patient care or the role of the physician in that process.
House Bill on Interchangeable Biosimilars
To show support of Virginia House Bill 1422 on interchangeable biosimilar biological products, which is consistent with ASBM’s principles on interchangeability, Dr. Dolinar and ASBM members sent letters to members of the House Committee on Health, Welfare and Institutions. HB 1422 limits automatic substitution of biologics to those deemed interchangeable by FDA and requires physician notification in a reasonable time frame following substitution.
GHLF Virginia House Biosimilars Letter
Kidney Cancer Association Letter
American Academy of Dermatology Letter
Senate Bill on Interchangeability
ASBM and several of our members signed onto a letter opposing Senate Bill 1285, urging the Senate to adopt all of all patient protections that the House included in their HB 1422, especially that:
- Substitutions for biologic medicines only be allowed in cases in which the Food and Drug Administration has certified that a biosimilar product is interchangeable.
- Substitutions for biologic medicines only be allowed in cases in which the Food and Drug Administration has certified that a biosimilar product is interchangeable.
- Records of biosimilar substitutions be kept for a period of no less than two years from the dispensing date.
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Archive
Virginia State Senator Herring Honored as BIO Legislator of the Year
June 17, 2011
The Biotechnology Industry Organization (BIO) announced today its selection of Virginia State Senator Mark Herring (D) of Leesberg as Legislator of the Year for 2009-2010. Senator Herring received the award today in the Virginia pavilion at the 2010 BIO International Convention taking place this week in Chicago, IL. Read More
Bioscience Industry in Virginia
June 17, 2011
The greatest concentration of companies, approximately 34%, is located in Northern Virginia. The greater Richmond region is second with 30%, the Charlottesville area with 15%, Western Virginia with 14% and the balance located in Hampton Roads. Read More
VaBio Public Policy
June 17, 2011
The Virginia Biotechnology Association (VaBIO) focuses on public policy issues facing the biosciences at the state and federal level. Members work to educate policy makers about the industry and the significant impact it has on Virginia. Read More
Virginia Bioscience Legislative Caucus
June 17, 2011
The Virginia Bioscience Legislative Caucus (VBLC) is a bi-partisan, bi-cameral group of approximately 60 state legislators who share a common interest in the development of the bioscience industry in the Commonwealth of Virginia. The caucus is co-chaired by Delegate John O’Bannon and Senator Janet Howell. Read More
June 17, 2011
Biotechnology Institute Chesapeake Bioscience Education Foundation Northern Virginia Life Sciences Communities Virginia Bioscience Legislative Caucus Virginia Biotechnology Association Virginia Biotechnology Center Virginia Council on Advanced Technology Skills Virginia Department of Health Virginia General Assembly Virginia Tech Department of Biological Sciences Virginia Tech Fralin Life Science Institute Medical Society of Virginia Office of Governor Bob McDonnell […]
