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ASBM publishes paper on biosimilar naming

The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.

The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?’ explains the ASBM’s position that in order to ensure patient safety as biosimilars are approved in the US, they must be given distinct, non-proprietary names. The paper identifies key challenges and practical solutions to help facilitate a solution to ensure safety is the cornerstone of the biosimilars pathway.

Read full article at Generics and Biosimilars Initiative (GaBI)

Background Image

ASBM publishes paper on biosimilar naming

The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.

The paper titled ‘It’s all about the name: what is the imperative of adopting unique names for biologic and biosimilar therapeutics?’ explains the ASBM’s position that in order to ensure patient safety as biosimilars are approved in the US, they must be given distinct, non-proprietary names. The paper identifies key challenges and practical solutions to help facilitate a solution to ensure safety is the cornerstone of the biosimilars pathway.

Read full article at Generics and Biosimilars Initiative (GaBI)

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