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Celltrion Seeks Marketing Authorization for CT-P42 (biosimilar, aflibercept) in the US

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Celltrion

Celltrion Seeks Marketing Authorization for CT-P42 (biosimilar, aflibercept) in the US

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  • The company has filed an NDA with the US FDA for CT-P42, a biosimilar referencing Eylea (aflibercept) to treat patients with ocular diseases & apply for marketing authorization for all Eylea's indications, excl. wAMD and DME, based on the P-III trial results
  • The P-III trial results showed confirmed equivalence and similarity to the Eylea. The company also plans to file for approval of CT-P42 in other key global markets, incl. EU
  • Additionally, the drug's exclusivity rights in the US expire in May 2024 and its patents in EU in Nov 2025. The company plans to complete global license applications for ~5 biosimilars, incl. CT-P42 within the year

Ref: KoreaBio  | Image: Celltrion

Related News:- Celltrion Initiates P-III Study of CT-P42 (biosimilar- aflibercept)

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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