FDA's 1st biosimilar adcomm: a lovefest
This article was originally published in Scrip
Executive Summary
From the get-go, the 7 January meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) was a lovefest between regulators and the filgrastim biosimilar from Novartis and its Sandoz unit, known as Zarxio, which won the panel's unanimous support.
You may also be interested in...
Enbrel Biosimilar Market In Sandoz's Grasp; Will Cost, Litigation Derail It?
With the FDA giving an overwhelmingly positive review of Sandoz Inc.'s application for its biosimilar version of Enbrel (etanercept), which is sold in the US by Amgen Inc., the product appears to be headed to the US market – pending a likely blessing from the agency's advisory panel, which is meeting on July 13. But Sandoz must still get past litigation and convince prescribers and patients its etanercept biosimilar provides value over Enbrel.
Enbrel Biosimilar Market In Sandoz's Grasp; Will Cost, Litigation Derail It?
With the FDA giving an overwhelmingly positive review of Sandoz Inc.'s application for its biosimilar version of Enbrel (etanercept), which is sold in the US by Amgen Inc., the product appears to be headed to the US market – pending a likely blessing from the agency's advisory panel, which is meeting on July 13. But Sandoz must still get past litigation and convince prescribers and patients its etanercept biosimilar provides value over Enbrel.
Moderna's Valera Takes mRNA Approach To Combat Zika
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.