Biosimilars in the US: Rising applications and approval rates

By Maggie Lynch

- Last updated on GMT

(Image: Getty/ Artem_Egorov)
(Image: Getty/ Artem_Egorov)

Related tags Biosimilars Biologics Humira Fda Regulations

Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.

Following on from an update on the progress of biosimilars in the UK and Europe​, after speaking with director general of the British Biosimilar Association, Warwick Smith, BioPharma-Reporter outlines similar signs of the strength of the market in the US.

Approvals for biosimilar medications for Humira (adalimumab), Remicade (infliximab), Herceptin (trastuzmab), among others, have been seen in 2018, taking total approvals by the US Food and Drug Administration (FDA) to 16. With both approvals and expirations, the market for biosimilars is growing thereby reducing direct spending and it is forecast to continue to do so. 

To be approved biosimilars must demonstrate data that compares the proposed product to the already FDA-approved biologic reference product. 

As of 2018, only two biosimilar medications are marketed in the US: Sandoz's Zarxio (filigrastim-sndz) biosimilar for Neupogen, and Merck's Renflexis​ (infliximab) biosimilar for Remicade. The biosimilar entered the marketed under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis. 

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