Biosimilars Have Arrived: Rituximab

Table 1

Biosimilars of rituximab in development [32].

Potential biosimilar (manufacturer	Development details
ABP 798 (Amgen)	Comparative efficacy and safety clinical trials in RA and NHL (ongoing) [33]
BX2336 (BioXpress Therapeutics)	In the company pipeline [34]
CT-P10 (Celltrion/Hospira)	Application submitted to EMA in Nov 2015 [35] and approved Feb 2017 [12]
Plant-produced rituximab biosimilar (iBio)	Rituximab produced in nontransgenic plants [36]
MabionCD20 (Mabion)	Comparative efficacy and safety clinical trials in NHL and RA (ongoing) [37]
PF-05280586 (Pfizer)	PK study in RA (completed); comparative efficacy and safety study in follicular lymphoma (ongoing) [19, 38]
GP2013 (Sandoz)	Application submitted to EMA in May 2016 [39]
L01XC02 (Sandoz)	Application approved by EMA in June 2017 [11]

biologics in development or approved under regulatory processes without the rigorous evaluation of biosimilarity defined by the EMA, FDA, or WHO guidelines are not included in this table; EMA, European Medicines Agency; FDA, US Food and Drug Administration; NHL, non-Hodgkin’s lymphoma; PK, pharmacokinetics; RA, rheumatoid arthritis; WHO, World Health Organization.