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FDA advisory committee recommends approval of Celltrion’s Truxima

2018.10.12 09:30:34 | 2018.10.12 09:31:02
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Celltrion announced on Thursday the U.S. Food & Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of Truxima, a biosimilar for the monoclonal antibody rituximab (Rituxan), for non-Hodgkin lymphoma indications in a 16-0 vote, paving the way for a positive decision from the U.S. regulator.

The advisory panel meeting took place at the FDA’s White Oak Campus in Maryland on Wednesday.

Truxima is already approved in Europe for all indications (malignant and nonmalignant) of the reference Rituxan.

The independent panel provides comprehensive feedback about quality, safety and cost effectiveness of a drug under regulatory review. Its positive recommendation strongly suggests the biosimilar will be cleared by the FDA.

The FDA convened its Oncologic Drugs Advisory Committee (ODAC) at its White Oak Campus in Maryland on Wednesday to vote about its recommendation of Celltrion’s Truxima, a Rituxan biosimilar.

The FDA convened its Oncologic Drugs Advisory Committee (ODAC) at its White Oak Campus in Maryland on Wednesday to vote about its recommendation of Celltrion’s Truxima, a Rituxan biosimilar.

Celltrion expects the FDA’s final decision to come sometime between late November and early December, which will make Truxima the first approved Rituxan biosimilar in the U.S. Celltrion aims to highlight that Truxima is the first mover in the Rituxan biosimilar market in its marketing campaign to gain doctors’ awareness.

Rituxan sales amount to around 5 trillion won ($4.37 billion) in the U.S., which accounts for 56 percent of worldwide sales.

Israel-based generics giant Teva Pharmaceutical Industries will be responsible for local distribution of Truxima.

By Shin Chan-ok and Minu Kim

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]

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