Celltrion, Inc.
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Latest From Celltrion, Inc.
US Drug Shortages Aid Aurobindo’s Q4 Growth, Decentralized Trials On For Xolair Biosimilar
Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair, as predicted by Scrip earlier. Use of decentralized mode for its Phase III trials is a notable aspect
Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.
Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.
Celltrion Goes It Alone With First Solo US Biosimilar Launch
Celltrion is taking a major step forward in the US with its first direct launch of a biosimilar through its own front-end operation. The Korean firm’s Vegzelma rival to Avastin will be looking to compete with multiple other versions of bevacizumab already in the market.
Company Information
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Pharmaceuticals
- Generic Drugs
- OTC, Consumer
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Biotechnology
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Large Molecule
- Antibodies
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Large Molecule
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- Bio CDMO
- Celltrion Healthcare Hungary Kft
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