August 24, 2022 01:30 PM EDTUpdated 04:51 PM

Interchangeability without switching studies: FDA explains why a new Lucentis biosimilar may be a game-changer

Zachary Brennan

Senior Editor

Of the nearly 40 biosimilars approved to date by the FDA, only three have won the coveted interchangeability designation so far, meaning that like small …

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Interchangeability without switching studies: FDA explains why a new Lucentis biosimilar may be a game-changer

Zachary Brennan

Senior Editor

Sign up to read this article for free.

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In­ter­change­abil­i­ty with­out switch­ing stud­ies: FDA ex­plains why a new Lu­cen­tis biosim­i­lar may be a game-chang­er

Zachary Brennan

Senior Editor

Sign up to read this article for free.

Among phar­ma CEOs, the IRA now and the IRA lat­er get very dif­fer­ent re­ac­tions

Bris­tol My­ers restarts ra­dio­phar­ma­ceu­ti­cal Phase 3 tri­al, but de­lays read­out by one year

Up­dat­ed: With cost-cut­ting un­der­way, Bris­tol My­ers rais­es guid­ance, touts Phase 3 win and scraps an­oth­er

An­drew Left, short sell­er who cam­paigned against Valeant, is ac­cused of fraud by SEC

Eu­ro­pean drug reg­u­la­tor re­jects Alzheimer's drug Leqem­bi, cit­ing safe­ty con­cerns

Crit­i­cal Junc­tures in Gene Ther­a­py Clin­i­cal Ma­te­r­i­al Man­u­fac­tur­ing: Where Do I Start? And Will It Work?

Interchangeability without switching studies: FDA explains why a new Lucentis biosimilar may be a game-changer

Among pharma CEOs, the IRA now and the IRA later get very different reactions

Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout by one year

Updated: With cost-cutting underway, Bristol Myers raises guidance, touts Phase 3 win and scraps another

Andrew Left, short seller who campaigned against Valeant, is accused of fraud by SEC

European drug regulator rejects Alzheimer's drug Leqembi, citing safety concerns

Critical Junctures in Gene Therapy Clinical Material Manufacturing: Where Do I Start? And Will It Work?