Organon Believes It Can Beat Out Other Humira Rivals In US

PBMs Likely To List ‘Two Or Three’ Adalimumab Biosimilars On Formulary

As the biosimilars industry awaits several US adalimumab launches in 2023, Organon has set out the reasons why it believes it can stand out from its competitors.

Red Chess Pawn Standing Out From Row Of Black Pawns
Organon thinks it can stand out from the competition on adalimumab • Source: Shutterstock

As Organon recently reported biosimilars sales that slid slightly in the third quarter – with ‘lumpy’ factors such as tender timings obscuring a performance that is expected to deliver double-digit growth overall this year (see sidebar) – CEO Kevin Ali took the opportunity of the Q3 earnings call to talk up the firm’s prospects for its launch of Hadlima (adalimumab-bwwd) in the US next year.

The Samsung Bioepis-developed Humira biosimilar was approved in a 50mg/ml formulation in mid-2019 (Also see "Samsung Bioepis Gets US...

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UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C7

 
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The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C6

 
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The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

US Biosimilars

An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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