The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA.

Online Course • grapl

About the CPD course

Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics and accompanying regulatory guidance from the Food and Drug Administration (FDA); have been established only in recent years. This module describes the provisions of the Biologics Price Competition and Innovation Act; identifies criteria for licensing a follow-on biologic as ‘biosimilar’ or ‘interchangeable'; specifies periods of market exclusivity that apply; and discusses patent infringement issues. Finally; it describes the provisions of the Biosimilar User Fee Act.

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grapl

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grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.