70 Stakeholder Groups Call on the FDA, Urging Distinguishable, Meaningful Suffixes for Biosimilars

May 11, 2016

WASHINGTON, DC—In a letter to the FDA this week, a 70-group coalition of healthcare stakeholders including patient and provider organizations and others urged the use of distinguishable, meaningful suffixes for biosimilars. The letter to Leah Christl, Ph.D., FDA’s associate director for therapeutic biologics, comes on the heels of FDA’s departure from a meaningful to random […]

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70 Stakeholder Groups Call on the FDA, Urging Distinguishable, Meaningful Suffixes for Biosimilars

May 11, 2016

WASHINGTON, DC—In a letter to the FDA this week, a 70-group coalition of healthcare stakeholders including patient and provider organizations and others urged the use of distinguishable, meaningful suffixes for biosimilars. The letter to Leah Christl, Ph.D., FDA’s associate director for therapeutic biologics, comes on the heels of FDA’s departure from a meaningful to random […]

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ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling

October 14, 2015

For Immediate Release: October 13, 2015 WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling. “This survey reinforces what ASBM has been hearing from pharmacists […]

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ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”

September 1, 2015

The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival […]

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Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 2015

SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015. ASBM chairman Dr.Harry Gewanter provided the […]

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Physician Confidence Critical to Biosimilar Adoption, Says Panel

June 1, 2015

SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015. ASBM chairman Dr.Harry Gewanter provided the […]

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GaBI: Physicians’ views on biosimilars labelling

April 20, 2015

On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their […]

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GaBI: Physicians’ views on biosimilars labelling

April 20, 2015

On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their […]

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The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive. You’ve heard about them […]

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The Jersey Journal: Making sure new medicines are safe

March 9, 2015

Most of the pills and injectable medications you take today are made from inert materials in a lab somewhere, but the stuff you may take next year could be made from body cells or plants.  They work really well. Perhaps they’ll even cure your problem, but currently they are very expensive. You’ve heard about them […]

Read More