Status: Approved in EU as a biosimilar in Sept. 2013

Organizations involved:

Celltrion Ltd. – Manuf.; R&D; Tech.;

Hospira – World mark.

Cross ref.: See the Remicade entry (no. 264), the reference product for this biosimilar.

Description: Infliximab is a biosimilar version of Remicade similarly containing a lyophilized (freeze-dried) powder formulation of a recombinant chimeric (partially humanized) murine IgG1kappa monoclonal antibody glycoprotein having specificity for human tumor necrosis factor alpha (TNF-alpha) produced by a transformed murine SP2/0 cells. Infliximab involves the variable or antigen-binding region of a murine immunoglobulin G1 (IgG1) monoclonal antibody (designated A2) with high-affinity and specificity for TNF-alpha, and the constant (Fc) or framework regions of human IgG1kappa immunoglobulin (i.e., murine variable region swapped with the human variable region). Infliximab contains approximately 30% murine variable region amino acid sequence, which confers antigen-binding specificity to human TNF-alpha. The remaining 70% corresponds to a human IgG1 heavy chain constant region and a human kappa light chain constant region.

Nomenclature: TNF Mab, rDNA/Celltrion [BIO]; Infectra [TR US]; Remsima [TR Intl.]; infliximab [FDA USAN INN]; immunoglobulin G, anti-(human tumor necrosis factor) (human-mouse monoclonal cA2 heavy chain), disulfide with human-mouse monoclonal cA2 light chain, dimer [CAS]; 57894-0030-01 [CAS RN]; cA2 [SY]; chimeric IgG1 anti-human TNF MAb cA2 [SY]; TNF-alpha MAb cA2 [SY]; tumor necrosis factor-alpha monoclonal antibody [SY]; L04AB02 [SY]

Companies: This biosimilar mAb was developed and is manufactured by Celltrion. Hospira has marketing rights in most territories.

< FDA class: Biologics (BLA or bBLA)

Status: European Union (EU) biosimilar application was filed in April 2012, and approved in Sept. 2013.

Tech. transfer: Celltrion has asserted that there are 18 countries within Europe where composition-of-matter patents do not exist, with initial launch of the product likely to be focused on these countrries in Eastern and Central Europe and the Nordic markets. Intellectual property is set to delay initial availability in the large five EU markets (Germany, UK, France, Italy and Spain) until at least 2014.