Biosimilars For US Market May Be Able To Rely On EU-Licensed Reference Products
Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.
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CREATES Act To Face Major Reshaping By Innovator-Friendly Amendments On Senate Floor
The Creating and Restoring Equal Access to Equivalent Samples Act clears US Senate Judiciary Committee. During markup, Sens. Hatch, R-Utah, and Cornyn, R-Tex., preview future amendments that would benefit innovators.
Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List
Generic companies might get more transparency than they bargained for if there is misuse of the public list of reference drugs they say they have trouble obtaining; at BIO annual meeting, FDA Commissioner Gottlieb also suggests VA procurement of brand drugs as possible alternative if innovators continue to hinder access for bioequivalence testing.
Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.