US Has Opportunity To Lead On Ophthalmic Biosimilars

Cardinal Health’s Sonia Oskouei Expands On Findings Of 2022 Biosimilars Report

With key milestones on the horizon for US biosimilars in 2022 and 2023, Cardinal Health’s vice president of biosimilars, Sonia Oskouei, explains how the industry can best position itself to take advantage of these upcoming opportunities – including potentially a global leadership role in ophthalmology – in an exclusive interview with Generics Bulletin.

Turning Point Sign
Cardinal Health says 2022 will be a turning point for US biosimilars • Source: YAY Media AS / Alamy Stock Photo

After a gradual ramp-up in the US biosimilars market since the Biologics Price Competition and Innovation Act first created the framework for US biosimilars in 2009, recent years have seen progress accelerate, with several major leaps forward.

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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.

Top 10 Drugs Q1 2026: New Sheriff In Town As Mounjaro Unseats Keytruda - Clone - Clone

Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains

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For Generics, A Victory Lap – And A Warning – On Drug Shortages

Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.

GB-Free-Company-The Secret to Walking More: It’s Not Counting Steps

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Biocon And Teva Sign Up To Biosimilars Forum

Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.