Mabpharm Seeks Approval of Infliximab Biobetter in China

Mabpharm has filed an application with China’s National Medical Products Administration (NMPA) seeking approval of a biobetter of infliximab, a biological treatment for people with ankylosing spondylitis and other inflammatory disorders.

Sorrento Therapeutics, the company owning global rights to the biobetter antibody outside of China, plans to file a biologics license application in the United States for the same purpose. The submission is planned by the end of this year, according to a press release.

Biobetter antibodies have the same target, but have been engineered to have improved properties, compared to their reference medicines, such as greater effectiveness or longer duration in the bloodstream. As do biosimilars, which are biological medicines highly similar to a brand product, biobetter antibodies may have lower costs than reference therapies. (Reference medicine refers to another biologic medicine that already is licensed by regulatory authorities.)

Infliximab, which is sold by Janssen under the brand name Remicade and by Celltrion as Remsima, is a tumor necrosis factor (TNF)-alpha inhibitor. TNF-alpha is a pro-inflammatory molecule that helps the immune system fight diseases and infections. In ankylosing spondylitis, excessive levels of TNF-alpha contribute to over-activation of the immune system that results in pain and swelling in the joints of the spine.

Infliximab usually is given only after treatment with other medications has failed. Besides ankylosing spondylitis, it is used in moderate-to-severe rheumatoid arthritis, Crohn’s disease and ulcerative colitis (two forms of inflammatory bowel disease), chronic severe psoriatic arthritis, and psoriatic arthritis.

In the U.S., other current TNF inhibitors include Humira (adalimumab, by AbbVie), Cimzia (certolizumab, by UCB), and Simponi (golimumab, by Janssen). Approved infliximab biosimilars in the U.S. include Amgen‘s Avsola, Pfizer‘s Inflectra and Ixifi, and Merck‘s Renflexis.

Recently, Mabpharm submitted a different new drug application to the NMPA seeking approval of a recombinant (engineered) anti-TNF-alpha monoclonal antibody based on infliximab for the treatment of moderate-to-severe active rheumatoid arthritis.

According to the company, the technology used to develop this potential therapy — known as CMAB008 — may lead to a better safety profile and lower immunogenicity (less ability to induce an immune response) compared to currently available medications.

Mabpharm also is developing a similar version of adalimumab for people with autoimmune diseases such as ankylosing spondylitis.