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New courses on generics and biosimilars in the USA
Zenosis, the leading provider of eLearning for the medicinal products industry, has released two new courses on generics and biosimilars in the USA:
- SUB13: How to Gain Approval to Market a Generic Drug in the USA
- SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
SUB13 outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ëOrange Bookí is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the review and approval process carried out by the Food and Drug Administration (FDA). An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the lawís effects on industry players.
The course is up to date with the many final and draft publications released by the FDA in US fiscal year (FY) 2017 that provide guidance for industry on applications for approval of generic drugs. It is also up to date with the provisions of the second authorisation of GDUFA, applicable from FY 2018.
The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. 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 FDA, have been established only in recent years.
The short course SUB14 describes the provisions of the Biologics Price Competition and Innovation Act, identifies criteria for licensing a follow-on biologic as ëbiosimilarí or ëinterchangeableí, specifies periods of market exclusivity that apply, and discusses patent infringement issues. Finally, it describes the provisions of the Biosimilar User Fee Act, which authorises the FDA to collect fees from follow-on biologics sponsors, to support review activities.
SUB13 will benefit staff working in regulatory affairs, medical affairs, clinical development, quality/CMC, analytical methods, and quality assurance departments, and other personnel who contribute to the development and registration of generic drugs. SUB14 will mainly benefit regulatory affairs staff concerned with the licensure of follow-on biological products.