Alliance for Safe Biologic Medicines

03/10/2022

ASBM Chairman Ralph McKibbin, MD shares physician perspectives about the Non-Medical Switching of patients on biologic medicines. Data comes from ASBM's latest survey of 401 US physicians drawn from a cross-section of specialties- all of whom prescribe biologic medicines.

Ralph McKibbin, MD discusses physician perspectives on Non-Medical Switching of patients on biologic medicines. Dr. McKibbin cites data from a survey of 401 ...

03/05/2022

Save the Date: from the experts on May 10-11, 2022! ASBM is a proud sponsor of the Biosimilars Training Program put on by Global Colon Cancer Association in partnership with the World Patients Alliance. The event is open to patient advocates worldwide, from all disease states. Registration opens soon! Visit LearnBiosimilars.org to learn more!

for our program on May 10-11, 2022. This free online training is designed for all organizations & advocates, not just . You'll learn about the benefits and challenges of biosimilars and how to bring your voice to the biosimilar topic. Thank you to our partner World Patients Alliance and sponsors Amgen and Alliance for Safe Biologic Medicines Visit http://learnbiologics.org

03/20/2019

Dear ASBM Supporters,

Below is ASBM's statement in support of the FDA's recent update to its Naming Guidance:

ASBM commends the decision by FDA to apply distinguishable suffixes to all biologics, including interchangeable biosimilars, going forward. FDA’s decision puts in place a protocol for a safe future, when there are many more biologics, biosimilars and interchangeable biosimilars. This policy ensures that patients and health care providers can distinguish between products when that is important for a patient’s care or to report adverse events.

We understand FDA’s thoughtful, solution to the difficult conundrum of products approved prior to adoption of the suffix policy. FDA will not change the nonproprietary names of already approved products in order to avoid confusion that could result. For these long-standing products, the brand name will be the distinguishing element and require more vigilance and effort by prescribers. This exception to the suffix protocol will ultimately play a role in the traceability of a limited number of biologics given that most products will not have biosimilars due to the challenges of biosimilar development.

This statement has also been shared on ASBM's Twitter account and we encourage you to retweet it.
Thanks,
ASBM

11/28/2017

‪Today we present data at the European Alliance for Personalized Medicine on protecting patient’s rights to access personalized treatment. Threats from regulators and payors exist worldwide. ‬

10/09/2017

On October 2nd, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) published a letter-to-the-editor signed by ASBM Chair Madelaine Feldman MD and three physicians from ASBM's International Advisory Board: Brazilian rheumatologist Valderilio Azevedo, MD; Canadian gastroenterologist Brian Bressler MD; and Alejandro Mercedes MD, oncologist from the Dominican Republic.

The letter urges national regulators to support the World Health Organization's (WHO's) proposed Biological Qualifier (BQ) system for ensuring clear identification of all biologics, including biosimilars:

"... in Europe, five different biological medications manufactured by seven different companies, all sharing the non-proprietary name ‘filgrastim’ are currently being sold. While each is marketed by its trade name in Europe, many physicians around the world, including in Europe, prescribe using the non-proprietary name alone. This ambiguity leaves it unclear to the dispenser which biological medicine was intended, and unclear to the prescriber which was actually received by the patient. This makes it difficult to accurately assess which drug the patient is responding to or having a side effect from."

We encourage you to read the full letter online here.

When a patient experiences an adverse event from a medication or the medicine stops working, it is important for both the patient and their physician to know