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FDA Is Urged To Make All Biosimilar Insulins Interchangeable

 
• By Dave Wallace

As part of feedback on the future of insulin biosimilars in the wake of FDA guidance over transitioning insulins to biologic status, the agency has been urged to deem all biosimilar insulins interchangeable as well as to push back against originator attempts to shield individual product ‘ecosystems’ from competition.

Insulin
The Agency Is Evaluating Input On Insulins • Source: Shutterstock

Demonstrating biosimilarity for insulin products in the US “should automatically generate an interchangeability designation”, according to comments submitted to the US Food and Drug Administration by Biocon as part of a consultation revolving around increasing access to and facilitating development of biosimilar and interchangeable insulins.

Under FDA guidance, on 23 March 2020, all FDA-approved insulins will switch from new drug application (NDA) status to 351(a) Biologics License Application (BLA) status – the pathway for original biologic applications, as opposed to the 351(k) BLA pathway for biosimilars – including ‘follow-on’ insulin products already approved under the 505(b)(2) NDA pathway

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UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.

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.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

More from Policy & Regulation

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By Dave Wallace

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Medicines UK Welcomes NHS England’s Best-Value Biologics Biosimilar Adoption Framework

 
• By Adam Zamecnik

Reflecting on recent initiatives by NHS England and the MHRA, the newly renamed trade body Medicines UK has welcomed efforts in promoting the use of biosimilars in Britain.