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Latest From Teva Pharmaceutical Industries Ltd.
Keeping Track: US FDA Approves Zokinvy, Defers Liso-Cel, Declines ALKS 3831 And Zimhi; Two Biosimilars Filed
The latest drug developments news and highlights from the Pink Sheet’s US FDA Performance Tracker
Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
BsUFA III: Sponsors Want Formal Meetings That Don’t Require Product Analytic Data
An early meeting option is needed so sponsors can discuss clinical trial endpoints and similar issues before analytic data is available, industry tells the US FDA.
Alvotech Files Higher-Strength Adalimumab In US And EU
Alvotech has announced the filing of its AVT02 higher-strength adalimumab version of Humira 100mg/ml with both the FDA and the EMA, as well as disclosing expected decision dates. Teva will market the biosimilar in the US and Stada in Europe.
Company Information
- Industry
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Pharmaceuticals
- Generic Drugs
- OTC, Consumer
- Other Names / Subsidiaries
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- ABIC Marketing Limited
- AbZ-Pharma
- Auspex Pharmaceuticals, Inc. (Imphar AG)
- Barr Pharmaceuticals
- Bentley Pharmaceuticals
- BioGeneriX AG
- BioAssets Development Corporation
- Cephalon, Inc. (Arana Therapeutics (Peptech and EvoGenix)
- Ception Therapeutics
- ChemGenex Pharmaceuticals Limited
- CIMA Labs
- Gemin X Pharmaceuticals
- CT Arzneimittel GmbH
- Gecko Health Innovations
- IVAX Corporation
- Labrys Biologics
- Mepha
- MicroDose Therapeutx Inc.
- Neose Technologies, Inc.
- NuPathe, Inc.
- PLIVA HRVATSKA d.o.o.
- ratiopharm Group
- Sicor Biotech
- Representaciones e Investigaciones Médicas, S.A. de C.V.
- Taiyo Pharmaceutical Industry Co. Ltd.
- Teva Branded Pharmaceutical Products, R&D Inc.
- Teva Women's Health, Inc.
- Actavis Generics
- Anda, Inc.
- Uteron Pharma S.P.R.L.
- Teva Takeda Yakuhin Ltd.
- Teva Takeda Pharma Ltd.
- Teva Neuroscience, Inc.
- Teva Pharmaceuticals USA, Inc.
- Zeneus Pharma