Pfiz­er bris­tles at 'mis­lead­ing' com­ments from Big Phar­ma ri­vals Am­gen, Genen­tech on biosim­i­lars

Tak­ing is­sue with Am­gen, Genen­tech and oth­er ref­er­ence prod­uct spon­sors’ dis­sem­i­na­tion of mis­lead­ing in­for­ma­tion on biosim­i­lars, Pfiz­er is ask­ing the FDA to take ac­tion with new guid­ance on what’s ac­cept­able.

In a cit­i­zen pe­ti­tion filed Mon­day, Pfiz­er notes ex­am­ples of what it calls “in­ap­pro­pri­ate com­mu­ni­ca­tions” and “mis­lead­ing rep­re­sen­ta­tions and sug­ges­tions by ref­er­ence prod­uct spon­sors.” The is­sue at hand isn’t so much that the in­for­ma­tion is wrong, but that the state­ments im­ply that biosim­i­lars are not as safe or as ef­fec­tive as ref­er­ence prod­ucts.

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