The first in China! Mabotech submits omalizumab biosimilar drug listing application

On October 22, the CDE official website showed that the application for the marketing of omalizumab (freeze-dried powder injection) biosimilar drug for injection declared by Taizhou Maibotek Pharmaceutical was accepted by the State Food and Drug Administration.
This is the first omalizumab Application for domestic marketing of biosimilar drugs
.

Omalizumab is a human immunoglobulin E (Ig E) humanized monoclonal antibody produced by Chinese hamster ovary cells using genetic recombination technology.
The original research company is Novartis
.
Omalizumab for injection was approved for marketing in China as early as August 2017, and its trade name is Zhuo Le

Abroad, Omalizumab (trade name: Xolair) has been approved for the treatment of chronic idiopathic urticaria, chronic rhinosinusitis and nasal polyps
.
In addition, Novartis has developed for the treatment of allergic rhinitis, sinusitis, allergies and other food

Omazhu single antigen research products are jointly developed and commercialized by Novartis and Roche worldwide, with sales of 1.
251 billion US dollars and 1.
904 billion Swiss francs respectively in 2020
.

In China, the original product as an exclusive negotiation product was successfully included in the medical insurance category B catalog in 2019, and the winning price was 1406 yuan (150mg*1 bottle/box)
.
The negotiation agreement will expire on December 31, 2021

New medical insurance negotiations are coming soon, and Novartis omalizumab is on the preliminary review list
.
At that time, the payment standard will be re-determined in accordance with the agreement

According to the PharmaGo database of Medicine Cube, in addition to the listing of Mabotech Pharmaceuticals, CSPC, Shanghai Baimaibo Pharmaceuticals, Hisun Pharmaceuticals, and Yuanda Healthcare are also developing biosimilars of this product
.
It is currently in the clinical stage

In addition, Novartis applied for the marketing of omalizumab injection (acceptance number: JXSS2101002/3) on April 10 this year, after treatment with inhaled glucocorticoids and long-acting inhaled β2-adrenergic receptor agonists , Still can not effectively control the symptoms of moderate to severe persistent allergic asthma
.
The applicable population is adults, adolescents (12 years old and above) and children (6 to <12 years old) patients