ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit

 
• By Derrick Gingery
  
Generate a summary of this article
Listen to this article
Beta

Generics must be able to be administered without provider intervention or patient retraining, draft guidance says.

FDA may have set a high bar for generic combination products in new draft guidance stating that the devices must not require provider intervention or patient retraining. Not only could the policy make it difficult for competing substitutable products to reach the market, but by raising the development cost, the studies could also limit some of the savings those generics could generate.

The agency's new draft guidance: "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Generics

Philippines Seeks Feedback On Plan To Recognize BE Studies Under ASEAN Deal

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

Finance Watch: Many Mega-Rounds, Some Smaller VC Deals, But Few In The Middle-Test-Sabbah

 
• By Sabbah

Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
• By Dean Rudge

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

Covid

More from Biosimilars & Generics

Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 
• By Bridget Silverman

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
• By Dean Rudge

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

EU Biosimilar Filings, Opinions And Approvals

 
• By Ian Schofield

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.