CSPC's Adalimumab Biosimilar Nears Approval as Fifth Domestic Entrant to Challenge $20 Billion Blockbuster Drug

Recently, the marketing application review status of CHIATAI TIANQING's Adalimumab Injection has changed to "Under Review" (Acceptance No.: CXSS2000026), and it is expected to be approved soon as the fifth China-produced Adalimumab biosimilar.

Adalimumab (Humira) is the world's first fully humanized monoclonal antibody against tumor necrosis factor-alpha (TNF-α) developed by AbbVie. It was first approved by the U.S. FDA in 2002 and received approval for marketing in China in 2010.

Humira has been approved for more than 17 indications globally and 8 indications in China: rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, moderately to severely active Crohn's disease, non-infectious intermediate/posterior/panuveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and moderately to severely active pediatric Crohn's disease.

It is worth mentioning that during the 2019 medical insurance negotiation process, Humira successfully entered the medical insurance with a 59% price reduction. As the 2021 edition of the National Medical Insurance Catalog was released, all eight indications of Humira have entered the National Medical Insurance Catalog.

Sales of Humira in Chinese Public Medical Institutions (Unit: 10,000 Yuan)

Source: MiNeiNet China Public Medical Institution Terminal Competition Pattern

According to AbbVie's financial report, the global sales of Humira in 2020 were $19.832 billion, ranking first among the world's best-selling drugs for nine consecutive years. With the support of medical insurance, Humira's market in China has also shaken off its sluggish state. Data from Menet shows that in 2020, the terminal sales of Humira in China's public medical institutions (referred to as urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) approached 800 million yuan, a year-on-year increase of 878.23%.

On November 4, 2019, Bio-Thera Solutions' Adalimumab Injection (brand name: Qletli) became the first China-produced adalimumab biosimilar. On December 6 of the same year, Hisun Pharmaceutical's Adalimumab Injection (brand name: Anjianne) was approved for marketing. On September 2, 2020, Innovent Biologics' Adalimumab Injection (brand name: Sulinan) was approved for marketing, and on December 2 of the same year, Henlius' Adalimumab Injection (brand name: Handayuan) was approved for marketing.

Approval Status of Adalimumab Biosimilars

Source: MiNei Network One-Click Search

As the registration status of CHIATAI TIANQING's Adalimumab Injection has changed to "under approval," the fifth China-produced Adalimumab biosimilar is about to emerge. Additionally, only Junshi Biosciences' product marketing application remains under review and approval.

Data source: MNI Database