ASBM Survey Shows Latin American Physicians Support Distinguishable Names

As the annual meeting of the Drug Information Association (DIA) June 15-18 in Washington DC, John Lewis of ASBM Steering Committee member the Association of Clinical Research Organizations (ACRO) presented data from ASBM’s physician surveys. 

The surveys, of specialists in 11 countries from practice areas in which biologics are routinely prescribed, quantify physician perspectives on biosimilar naming, substitution, and labeling.

Lewis shared for the first time data from ASBM’s Latin American Survey (May 2015), including the fact that 94% of respondents supported the WHO’s BQ proposal.

Other recent data being presented to the DIA includes results from ASBM’s Canadian Survey (Dec. 2014), its U.S. Survey on Labeling (Feb. 2015), as well as a comparative analysis of all 11 countries surveyed.  

The full Latin American survey results are available here. 

ASBM Leadership, Members Attend WHO Meeting in Support of BQ Proposal

On June 16, the World Health Organization’s (WHO’s) Consultation on International Nonproprietary Names (INN) held its Front Page Meeting for Stakeholders at WHO headquarters in Geneva, Switzerland. 

The meeting was held to finalize the WHO’s Biologic Qualifier (BQ) proposal, under which biosimilars would be made distinguishable from their reference products by the addition of a unique 4-digit code to the reference product’s INN. 

Representatives from ASBM were in attendance, including Chairman Dr. Harry Gewanter, Advisory Board Chair Dr. Philip Schneider, and representatives from several member patient groups. 

Please visit www.safebiologics.org for the latest updates on this meeting. 

ASBM Cited in Royal Pharmaceutical Society Coverage of WHO Naming Debate

The work of ASBM in the global naming debate was heavily referenced in a June 11 Pharmaceutical Journal article previewing the June meeting and examining the status of biosimilar naming policies of various regulatory authorities including those of the EMA and FDA.

The Pharmaceutical Journal is published by the Royal Pharmaceutical Society, the membership body for pharmacists in Great Britain. 

The article lays out a comprehensive picture of the naming debate, drawing heavily from ASBM’s work, including its research showing support for distiguishable naming among Canadian physicians. It also quotes ASBM Executive Director Michael S. Reilly extensively on the value of distinguishable naming, and discusses ASBM’s support for the WHO’s BQ proposal and its praise for the FDA’s use of a differentiating suffix in its first biosimilar approval, for Zarxio (filgrastim-sndz) March 2015. 

Read the full article here. 

ASBM Advisory Board Member’s Letter to Australian Health Minister Covered in PharmaDispatch

ASBM Advisory Board Member Stephen Murby, former Chair of the Consumers Health Forum and current biosimilars spokesperson for the International Alliance of Patients’ Organizations, has written a letter to Australian Health Minister Sussan Ley, reports PharmaDispatch in an article dated June 11th.

The letter addresses Mr. Murby’s concerns with indications given by the Australian government that it may begin to allow pharmacy-level substitution of biosimlars. 

In his letter, Mr. Murby calls this “an enormously retrograde step for Australia. One which is completely out-of-kilter with world best practice and which has the potential to reduce the standards of safe use of biosimilars for patients.” 

The letter was also sent to Shadow Health Minister Catherine King and Green Party Leader Senator Richard Di Natale. 

Read the PharmaDispatch article here. 

Second ASBM Pharmacist CE Class Success in CA 

On May 29, ASBM held it’s second continuing education (CE) class for pharmacists at the Chapman University School of Pharmacy in Irvine, CA. The three-hour class, “Biosimilars: What Every Pharmacist Needs to Know,” educated pharmacists on the fundamentals of biosimilars by providing pharmacists with an overview of what biologics and biosimilars are, how they are manufactured and the regulatory challenges associated with them.

In his presentation, Ronald P. Jordan, BPharm, RPh, FAPhA and Dean of the Chapman University School of Pharmacy and former President of the American Pharmacists Association (APhA), who participated in the first CE class, thanked ASBM for organizing a similar offering on the West Coast that provided the pharmacy community with a critically important education on a very pressing issue.

Philip J. Schneider, M.S., F.A.S.H.P., Professor and Associate Dean for Academic and Professional Affairs, University of Arizona College of Pharmacy and ASBM International Advisory Board Chair; ASBM Chairman Dr. Gewanter and ASBM Executive Director Michael Reilly also presented.

Read more here.

ASBM Meets with Administration on Naming 

On May 19, ASBM Chairman, Dr. Harry Gewanter, and Executive Director Michael Reilly, met with officials from the Executive Branch to disucss the need for clear naming of biosimilars. The meeting was attended by officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human Services (HHS).

ASBM provided the officials with an overview of it’s membership, and activities, and provided a clinical perspective on the use of biologic medicines, focusing on the need for clear identification, tracking, and communication.

Read more here.