Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress

According to the bills' text, these companion House and Senate bills are intended "to provide for the licensing of biosimilar and biogeneric biological products . . ." [...] the FTC report concludes, "market opportunities are likely to be sufficient to incentive [sic] development...

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Bibliographic Details
Published inBiopharm International Vol. 22; no. 7; p. 46
Main Author Del Buono, Brian J
Format Trade Publication Article
LanguageEnglish
Published Monmouth Junction MultiMedia Healthcare Inc 01.07.2009
Subjects
Bills
Biological products
Biotechnology industry
Clinical trials
Congressional committees
FDA approval
Federal regulation
Generic drugs
Licenses
Manufacturing
Market entry
Pediatrics
Pharmaceutical industry
Prescription drugs
Provisions
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Summary:According to the bills' text, these companion House and Senate bills are intended "to provide for the licensing of biosimilar and biogeneric biological products . . ." [...] the FTC report concludes, "market opportunities are likely to be sufficient to incentive [sic] development of interchangeable [follow-on biologies]" (id.), and that competition in the biologies market thus would be more akin to brand-brand competition rather than brand-generic competition in the small molecule arena.
ISSN:1542-166X
1939-1862