April 2014 Newsletter

Lawmaker Presses FDA for Guidance on Naming, Interchangeability Policies In a letter to FDA Commissioner Margaret Hamburg dated April 24, U.S. Rep. Anna Eshoo (D-CA) requested an update on FDA’s timeline for releasing guidance on biosimilar naming and interchangeability. “I believe clear and timely guidance on naming and interchangeability will allow both innovators and manufacturers […]

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March 2014 Newsletter

ASBM Releases EU Physicians’ Survey in Brussels On March 18th in Brussels, the Alliance for Safe Biologic Medicines (ASBM) released the results of a survey of 470 European physicians from five countries regarding their prescribing habits and knowledge of biosimilar medicines. Participants in the survey included specialists in the fields of nephrology, rheumatology, dermatology, neurology, […]

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February 2014 Newsletter

ASBM Forum Brings Together Leaders on Biosimilars Issues in 2014 On February 25th, the Alliance for Safe Biologic Medicines (ASBM) held a forum to educate patient advocates, physician groups and members of its International Advisory Board on the complex issues related to biosimilars. The half-day forum entitled, “Ensuring Access to Safe Biosimilars: Policy Developments and […]

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January 2014 Newsletter

WHO’s Minutes Reflect INN Consideration of Separate Process for ‘Biologic Qualifiers’ for Biosimilars As reported in Inside Health Policy’s “WHO Mulls ‘Biological Qualifier,’ Separate from INN, For Biosimilars,” minutes from the meeting held this past October in Geneva reflect the serious examination by World Health Organization to create a system for unique names. ASBM chairman […]

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November/December 2013 Newsletter

ASBM Releases New European Survey in Dublin On November 22, ASBM Executive Director Michael Reilly presented preliminary findings of a new survey on European physicians’ views on biosimilar naming at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety: 53% of physicians surveyed […]

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October 2013 Newsletter

FTC to Host Workshop on Biosimilars The Federal Trade Commission (FTC) will be holding a public workshop on December 10, 2013 in D.C. to discuss competition issues surrounding biologics and biosimilars. The workshop will specifically focus on how state regulations and naming conventions may impact the development of, and competition for, biosimilars. The FTC will […]

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September 2013 Newsletter

Dolinar Letter to the Editor Published by GaBI in Advance of WHO Naming Meeting On September 27th, a Letter to the Editor by ASBM Chairman Richard Dolinar, M.D. was featured in the Generics and Biosimilars Initiative Journal (GaBI). The piece commends the World Health Organization (WHO) for its attention to an upcoming action on the […]

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July – August / Summer 2013 Newsletter

Dolinar Authors Second Letter to WHO on Naming ASBM Chairman Richard Dolinar, M.D., submitted a letter on July 31, 2013, to Dr. Margaret Chan, World Health Organization Director-General to reiterate ASBM’s position on the importance of using distinct non-proprietary names to ensure patient safety. The letter was sent to Dr. Chan and to the INN […]

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June 2013 Newsletter

Inside Health Policy: “Safety, Generic Concerns Factors in Proposed AMA Biosimilar Resolution” A perceived lack of safety information about biosimilars and past problems with substitution of generic drugs led neurologists and rheumatologists to ask the American Medical Association to study the safety of follow-on biologics. AMA is expected to considerer the topic further at a […]

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May 2013 Newsletter

State Legislation Update Several state legislatures have have adjourned for the year, but we continue to urge support for California Senate Bill 598, which passed off the Senate Floor (29-4) on Friday, May 24. The bill now heads to the State Assembly where it is expected to be double-referred to the Assembly Business, Professions and […]

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