The long-awaited investigation into pharmacy benefit managers’ impact on drug accessibility and affordability in the US is here.
PBMs Hinder Access To Generics And Biosimilars, Finds FTC’s Investigation
The Biosimilars Forum And AAM Commend FTC, While PBM Association Hits Back
An FTC report has shown evidence of “troubling rebating practices” between pharma companies and PBMs, lowering access to generics and biosimilars. While off-patent groups commended the agency, the PBM association said the report falls short of being definitive or fact-based.
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FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.
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The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
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The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Generics Bulletin previews the most noteworthy and anticipated events for April 2025.