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Latest From Fresenius Kabi AG

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Generic Drugs User Fees

US Biosimilars Enjoy A Year Of Firsts In 2021

While US biosimilar approvals have been thin on the ground in 2021 – with products delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.

Outlook 2022 Market Access

Consolidation And COVID See Off-Patent Industry Rankings Rewritten

After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.

Sales & Earnings Biosimilars
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