Celltrion Reports Positive Data For High-Concentration Adalimumab
Phase III Trials Cover Two Delivery Methods For CT-P17
Celltrion’s phase III study comparing the pharmacokinetics, efficacy and safety profile of its CT-P17 high-concentration adalimumab biosimilar to Humira has yielded positive results. The company is presenting the results at the American College of Rheumatology Convergence 2020.
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Celltrion expects to receive the world’s first approval for a high-concentration adalimumab biosimilar rival to Humira, after receiving a positive opinion from the EMA’s CHMP for its CT-P17 candidate.
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.
Alvotech’s AVT02 proposed adalimumab biosimilar has seen positive results from two clinical trials. The high concentration dosage form of AVT02 differentes it from most of its biosimilar competitors.