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FDA’s Gottlieb Rolls Out A Raft Of Biosimilar Reforms

 
• By Dave Wallace

As the FDA publishes several key guidance documents on biosimilars and biologics, Commissioner Scott Gottlieb has outlined the latest steps in the agency’s ongoing efforts to support the market. These include measures to address the abuse of REMS, as well as transitioning products such as insulin and human growth hormone into the biologics framework.

Dr. Scott Gottlieb
FDA Commissioner Scott Gottlieb • Source: Shutterstock

Amid a flurry of newly-published guidelines on biosimilars and biologic drugs, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has set out his vision for the future of the US biosimilars market.

Referring to the US small-molecule generics market as “one of the most competitive generics markets in the world”, Gottlieb acknowledged that “not all parts of the pharmaceutical market have been equally open to competition from

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Amneal Proud To Be ‘Made In America’ And Ready To Scale Up Its US Manufacturing

 
• By Urtė Fultinavičiūtė

Amneal has set itself apart from competitors who are scrambling to find alternatives if proposed US pharmaceutical tariffs come into place. For the New Jersey-based firm, this is an opportunity to embrace its American identity and open a new chapter of growth.

‘I’ll Be Happy When We Have 40-Plus Assets’ – Sandoz Builds Up Biosimilars

 
• By Dave Wallace

With biosimilars playing an increasingly important role in Sandoz’s business, the firm’s first-quarter results call saw management lay out the latest key developments. Meanwhile, the company also addressed the issue of US tariffs, voicing optimism over both future developments as well as its ability to weather current measures.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
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CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

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Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
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US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

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