China’s NMPA Grants Greater Access to Rheumatology Biosimilars

Since the start of 2022, China’s National Medicinal Products Administration (NMPA) has made strides to increase access to biosimilar products for various rheumatic conditions, including 3 newly approved biosimilars and 1 biosimilar receiving approval for an expanded indication.

China has been an emerging market for quite some time, having its first biosimilar approval in February 2019, which was a rituximab biosimilar (Hanlikon) developed by Henlius Fuhong Henlius referencing Rituxan. Since then, the NMPA has authorized 24 more biosimilars, according to Big Molecule Watch’s Approved Biosimilars in China directory.

In January 2022, the NMPA approved Tabovi, also known as Taibowei, an adalimumab biosimilar referencing Humira. The biosimilar was developed by Chia Tai Tianqing Pharmaceutical. The drug was approved for the treatment of rheumatoid arthritis, axial spondyloarthritis, and psoriasis. Tabovi is based on the original version of Humira, meaning that it is a low-concentration injectable.

In addition to Tabovi, Junshi Biosciences and Mabwell Bioscience received an approval for another adalimumab biosimilar, named Junmaikang (UBP1211), in early March 2022. The NMPA approved Junmaikang for the same indications as Tabovi. Junmaikang represented the first commercial product to receive Chinese regulatory approval for Mabwll Bio.

Jumaikang was approved by the FDA in December 2021, becoming the seventh adalimumab biosimilar to be approved for the US market. The approval was conducted through a partnership between Junshi Biosciences and Coherus Biosciences, the latter of which will have the commercialization rights in the United States, where it will be marketed under the name Yusimry.

Tabovi and Junmaikang mark the fifth and sixth adalimumab biosimilars to receive regulatory approval for the Chinese market, respectively.

In February 2022, a third biosimilar approval was doled out to Genor Biopharma for its infliximab product, Jiayoujian (GB242). The product was indicated for rheumatoid arthritis, axial spondyloarthritis, psoriasis, adult ulcerative colitis, adult and pediatric Crohn disease, and fistulizing Crohn disease.

The approval was based on results from a phase 3 clinical trial that demonstrated comparable safety and efficacy profiled between the biosimilar and the originator, Remicade, in adult patients with rheumatoid arthritis. The trial included 570 patients and assessed the performance of the biosimilar and reference product through 30 weeks of treatment.

Jiayoujian is Genor Biopharma’s first commercial drug to receive regulatory marketing authorization.

“It is also an important milestone in Genor Biopharma's development and a successful example of the close cross-functional collaboration and excellent execution. I would like to thank all the patients and researchers who contributed to the successful clinical development of GB242, as well as the regulatory authorities for the thorough, professional and effective review to address the urgent and unmet medical needs of the vast number of Chinese patients,” said Guo Feng, MD, board chairman and CEO of Genor Biopharma, in a statement.

In addition to the recent approvals, Hanlikang, a rituximab biosimilar developed by Shanghai Helius Biotech, was granted a new indication for use in combination with methotrexate for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis who have had inadequate response to 1 or more tumor necrosis factor-alpha antagonist therapies.

The expanded indication provides an alternative treatment option for patients with autoimmune diseases who have struggled with other medications, such as adalimumab.

Hanlikang was originally approved for the Chinese market in 2019 for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. The biosimilar is the only rituximab product that has gotten approval for the treatment of rheumatoid arthritis in China.

“In addition to [our] adalimumab [biosimilar Handayuan], the approval for [Hanlikang] on rheumatoid arthritis is another milestone of Henlius in autoimmune diseases and will reach more patient population and provide them with alternative treatment options,” said Wenjie Zhang, chairman, executive director and CEO of Henlius, in a company statement.