Apotex biosimilar of Amgen's Neulasta under FDA review

The FDA has accepted another biosimilar application, this time Apotex's version of pegfilgrastim, which is referenced from Amgen's innovative drug Neulasta, which raked in about $3.6bn in sales in 2013.

The FDA has accepted another biosimilar application, this time Apotex's version of pegfilgrastim, which is referenced from Amgen's innovative drug Neulasta, which raked in about $3.6bn in sales in 2013.

The application was filed under the FDA's 351(k) abbreviated approval pathway, which was created by the Biosimilar Price Competition and...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Archive

Optimizing Drug Pipelines With Biophysical Methods

Optimizing Drug Pipelines With Biophysical Methods”, your view into how using biophysical techniques can enhance and streamline processes throughout the drug discovery and validation cycle.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

GSK Looks To Catch Up In mRNA Vaccines With New CureVac Deal

 

GSK will assume full control of mRNA shots in infectious disease, allowing CureVac to cut costs and pivot its research to oncology.

More from Scrip

EHA: Lilly’s Jaypirca Posts First Phase III Triplet Win In CLL While BTK Degraders Advance - Clone

Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.

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

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