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WHO Meetings in Geneva
ASBM Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on April 13 in Geneva. The two provided perspectives from both a physician and pharmacist viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.
Both plan to attend the WHO’s “Front Page Meeting with INN Stakeholders” that will be held in Geneva on June 16. This meeting will show the results of the comment data analysis process on the “Biological Qualifier: An INN Proposal” document.
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Pharmacists Raise Concerns on Labeling to FDA
On April 23, Philip Schneider, University of Arizona College of Pharmacy professor; Ronald P. Jordan, Chapman University School of Pharmacy Dean; and Joseph J. Bova, Long Island University College of Pharmacy Director of Continuing Education – the pharmacists that participated in the continuing education class with ASBM last month – sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug. Jordan is a former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP).
In the letter, they urged the FDA to consider a requirement for more informative labeling of biosimilars:
“Approval of these medicines is dependent on their meeting FDA’s thoughtfully-designed standards for safety and efficacy. Assuring the ready availability this information to prescribers and pharmacists will not only improve patient outcomes by promoting better-informed treatment decisions, it will serve to build overall confidence in biosimilars.“
Read the letter here.
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Quintiles Podcast on First FDA Approval
Nigel Rulewski, M.D., Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discussed the historic step the FDA took on March 6 approving the first ever biosimilar product for the U.S. market.
Listen to the podcast here.
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ASBM Labeling Survey Featured in GaBI Article
The April 17 Generics and Biosimilars Initiative (GaBI) article, “Physicians’ views on biosimilars labeling,” quotes Executive Director Michael Reilly on the recently released physicians labeling survey. The piece highlights the key points from the survey and the physicians’ support for transparent, clear labels.
“ASBM Executive Director, Mr Michael Reilly stated that ‘we believe this data provides FDA with clear guideposts for what is necessary to foster physician confidence in biosimilar medicines.’ He added that ‘the survey was conducted prior to the first biosimilar approval and is more consistent with the draft guidance released in 2012 than the label of the first biosimilar product.’”
Read the full piece here.
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In the States
Tennessee
Governor Haslam signed biosimilar legislation into law.
Georgia and Washington
Legislation has been passed and sent to the respective Governor to be signed.
California
On April 29, SB 671 was passed out of the Committee on Health and then sent to the Committee on Appropriations.
Louisiana
HB 319 passed the Health and Welfare Committee during the hearing on May 5. It scheduled for floor debate on May 14.
Maryland
The legislature in Annapolis adjourned on April 13 without passing SB 537.
Texas
SB 542 was referred to the Committee on Health and Human Services on April 21 and HB 751 passed the House as amended on April 14.
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Upcoming Conferences:
- May 27-28: USA World Biosimilars Congress 2015 in San Diego, CA
- May 29: ASBM Pharmacist CE Class in Orange County, CA
- June 1-4: Global Healthcare Conference in New York City, NY
- June 14-18: DIA 2015 51st Annual Meeting in Washington, DC
- June 16: WHO Front Page Meeting in Geneva
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