Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

For Biosimilars, A Mid-Review Cycle Product Quality Discussion Appears To Be A Bad Omen

27 Jan 2021

• By Derrick Gingery

scientist working with vat in lab — The report also indicated BPD Type IV meetings were valuable to biosimilar sponsors. • Source: Shutterstock

Related Content

BsUFA III: Sponsors Want Formal Meetings That Don’t Require Product Analytic Data

20 Nov 2020

BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?

04 Feb 2020

FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office

11 Sep 2019

PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications

13 Dec 2016

Additional Topics

United States Biosimilars User Fees Manufacturing Review Pathway Regulation Quality BioPharmaceutical

More from Biosimilars

More from Biosimilars & Generics

Twitter feed RSS feed RSS feed

About UsOpens in new window
Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us
Customer Service
Subscribe
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window

Copyright © 2025 Pharma Intelligence UK Limited (Citeline), a Norstella company Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered.