ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”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

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Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies

January 14, 2015

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM  international advisory board member. In the article he said: “Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle […]

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Videos Explaining the Biologics and Biosimilars

January 13, 2015

Amgen Canada has created two new videos explaining the differences between biologics and biosimilars. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved. Watch the videos here.

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Advocating for Patient Safety at FDA Hearing on Biosimilars

January 7, 2015

On January 7, Andrew Spiegel, executive director of the Global Colon Cancer Association and ASBM Steering Committee member, presented before the U.S. Food and Drug Administration (FDA) providing a patient perspective on why safety must be the ultimate priority when approving biosimilars. During his oral presentation before at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public […]

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