Innovent's Rituximab Biosimilar Set to Become China's Second Approved Version

By: Cai Cai

Recently, the New Drug Application (NDA) for IBI301, a rituximab biosimilar injection jointly developed by Innovent Bio and Eli Lilly (Acceptance No.: CXSS1900030), has been updated to "Under Review," with formal approval for marketing expected for the treatment of non-Hodgkin lymphoma (NHL).

(Source: NMPA)

Rituximab, originally developed by Genentech (later acquired by Roche), is the first monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer. Rituximab (brand names: Rituxan/MabThera) was approved by the U.S. FDA in 1997. Its approved indications in Europe and the United States include non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA). In April 2000, it was approved by the National Medical Products Administration (NMPA) of China for the indication of CD20-positive follicular and diffuse large B-cell non-Hodgkin lymphoma.

Rituximab has long been one of Roche’s three flagship products, consistently ranking among the top 10 global drugs by sales in recent years. In 2019, its global sales reached $6.86 billion, placing it 10th on the list of top-selling drugs worldwide; however, impacted by biosimilar competition, its sales declined by 4.0% year-on-year.

Currently, only Henlius and Innovent Bio have submitted marketing applications for rituximab biosimilars in China.

(Source: CDE)

In February 2019, Henlius’ rituximab injection (brand name: Hanlikang) was approved for marketing in China for the treatment of non-Hodgkin’s lymphoma. This drug is the first biosimilar approved in China and also the first biosimilar of rituximab globally.

With the entry of biosimilars, the next phase will be a price war.

In 2017, the originator rituximab product, MabThera, was included in the National Reimbursement Drug List through price negotiations, with the price of the 500 mg/50 mL/vial specification reduced to RMB 8,298 and that of the 100 mg/10 mL/vial specification reduced to RMB 2,418.

In May 2019, Hanlikang, newly approved at the time, was included in Shanghai’s negotiated procurement program following its inclusion in the municipal medical insurance reimbursement list. According to the “Notice on Publishing the Negotiated Procurement Prices for Certain Drugs Included in the Municipal Medical Insurance Reimbursement List (No. 31 [2019])” and the “Notice on Publishing the Fixed Out-of-Pocket Payment Standard for Rituximab Included in the Municipal Medical Insurance Reimbursement List” issued by the Shanghai Sunshine Pharmaceutical Procurement Network, the negotiated procurement price for rituximab was set at RMB 1,648, with a fixed out-of-pocket payment standard of RMB 650. These standards took effect on May 15.

(Source: Shanghai Sunshine Pharmaceutical Procurement Network)

Currently, Hanlikang has been included in the medical insurance payment scope in many regions. The online procurement prices in Shanghai, Guangxi, and Tianjin are all RMB 1,648 per bottle (100mg/10ml/bottle).

According to PDB research data, the current sales revenue of rituximab in domestic sample hospitals has exceeded 1 billion yuan.

With this approval of Innovent’s rituximab, it will become the third biosimilar approved for Innovent, following bevacizumab and adalimumab, and the fourth drug overall to gain market authorization for the company. Whether Innovent can sustain its performance with its portfolio of three major biosimilars remains to be seen over time.