Is Obinutuzumab on the market?

In November 2013, the U.S. Food and Drug Administration (FDA) approved obinutuzumab and chlorambucil as the first-line treatment of chronic lymphocytic leukemia. It was the first breakthrough therapy to be approved, with the trade name Gazyva. In February 2016, according to the priority review plan, octuzumab was approved by the FDA for use in combination with bendamustine. Subsequently, octuzumab was used as a single agent to treat patients with follicular lymphoma as a second-line treatment for rituximab-containing regimens.

As of 2014, clinical trials have been conducted to explore the use of otuzumabas a second-line monotherapy for relapsed/refractory chronic lymphocytic leukemia, as a monotherapy for relapsed/refractory non-Hodgkin lymphoma in people with high CD20 expression; and in combination with CHOP chemotherapy as a first-line treatment for patients with advanced CD20-positive diffuse large B-cell lymphoma. It was called GA101 during the study. In 2014, the European Medicines Agency (EMA) decided that the benefits of otuzumab outweighed its risks, so it was marketed and sold under the trade name Gazyvaro. In 2021, Otuzumab was approved by the National Medical Products Administration to be launched in China and sold under the trade name of Jia Luohua.

The patent drug Otuzumab, which is marketed in China, has entered the scope of medical insurance, but it is only reimbursed for patients who meet the indications. The price of a 1000mg (40ml)*1 bottle may be more than 9,000 yuan, and it is a strictly controlled drug. The price of the Turkish version of Otuzumab, 1000mg/40ml, per box sold overseas may be around RMB 10,000 (the price may fluctuate due to the exchange rate). The ingredients of the original drugs sold domestically and abroad are basically the same. There is currently no generic version of Otuzumab produced and launched. For more drug information and specific prices, please consult the medical consultant of Yaode.