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