Biosimilar Forum Biosimilar Suffixes, If Used, Should Be Meaningful

The group suggests FDA offer a tiered timeline that allows a manufacturer to first change the name and label with the agency and then fully implement the change in the marketplace.** *The group says the agency should hold a public workshop to gather stakeholder feedback on the issue and develop addi...

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Bibliographic Details
Published inInsideHealthPolicy.com's FDA Week Vol. 21; no. 44; p. 13
Main Author Wilson, Todd Allen
Format Journal Article Trade Publication Article
LanguageEnglish
Published Arlington Inside Washington Publishers 06.11.2015
Subjects
Biological products
Brand names
FDA approval
Generic drugs
Pharmaceutical industry
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Summary:The group suggests FDA offer a tiered timeline that allows a manufacturer to first change the name and label with the agency and then fully implement the change in the marketplace.** *The group says the agency should hold a public workshop to gather stakeholder feedback on the issue and develop additional guidance to lay out the details of the process.* "A maximum timeframe for implementation of a name change in the marketplace for the reference biologic should be determined with input from stakeholders at such public meeting.
ISSN:2165-4166