China’s NMPA Approves Innovent’s Adalimumab Biosimilar

Suzhou, China-based Innovent Biologics said that its adalimumab biosimilar (Sulinno) has received marketing approval from China’s National Medical Products Administration (NMPA).

“The launch of Sulinno once again fulfilled our mission to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. We hope that this product will benefit more and more patients and families in need and improve their quality of life,” Michael Yu, chairman and CEO of Innovent, said in a statement.

The drug referencing Humira is a recombinant human anti–tumor necrosis factor–alpha monoclonal antibody injection. Sulinno has been approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis.

In China, there are nearly 20 million patients with rheumatoid arthritis, ankylosing spondylitis, or psoriasis, according to Innovent.

Although the reference product is widely used in North America and Europe, Humira’s high costs make it difficult for the average patient in China to afford this drug, resulting in limited access to the medicine.

“The launch of Sulinno will provide more Chinese patients with high-quality and relatively affordable adalimumab injection[s], bringing hope and opportunities to more patients,” Innovent said.

Innovent’s Growing Portfolio

This is Innovent’s third monoclonal antibody to be approved by the NMPA. Tyvyt (sintilimab) received Chinese approval in 2019 and Byvasda (bevacizumab) received approval in June 2020.

Byvasda was approved in China for the treatment of non–small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

In January 2019, Innovent announced that Tyvyt, developed in partnership with Eli Lilly, had received NMPA approval for the treatment of Hodgkin lymphoma.

In May 2019, Innovent’s rituximab biosimilar candidate (IBI301), also developed in partnership with Eli Lilly, met primary end points in a phase 3 pharmacokinetic clinical trial. In June 2019, Eli Lilly announced that the NMPA accepted an application for IBI301’s marketing approval.

IBI301 references Rituxan, which is indicated for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

In addition to its biosimilar and novel biologics portfolio, Innovent also is developing an antibody treatment for coronavirus disease 2019 (COVID-19), according to the Milken Institute’s COVID-19 tracker.