Biosimilars in ophthalmology: “Is there a big change on the horizon?”

Figures & data

Table 1 Biosimilar of Lucentis^® (ranibizumab)

Name	Company	Approval (stage)
Razumab	Intas Pharmaceuticals Ltd. (Ahmedabad, India)	DGCI (2015) (Phase 4) approved
FYB 201	Formycon AG (Munich, Germany) and bioeq GmbH (Holzkirchen, Germany)	Expected approval US FDA (2020), EMA (2022) (Phase 3)
Xlucane	Xbrane Biopharma (Solna, Sweden)	Expected approval US FDA (2020), EMA (2022) (preclinical stage)
PF582	Pfenex Inc. (San Diego, CA, USA)	NA (Phase 1/2)
CHS3351	Coherus BioSciences (Redwood City, CA, USA)	NA (preclinical stage)
SB11	Samsung Bioepis (Incheon, South Korea)	NA (Phase 3)

Abbreviations: DGCI, Drug Controller General of India; EMA, European Medical Agency; NA, not approved; US FDA, United States Food and Drug Administration.

Table 2 Biosimilar of Eylea^® (aflibercept)

Name	Company	Approval (stage)
M710	Momenta Pharmaceuticals (Cambridge, MA, USA) and Mylan NV (Cambridge, MA, USA)	NA (pivotal trial 2018)
ALT-L9	Alteogen, Inc. (Daejeon, South Korea)	NA (IND filling with US FDA 2018)
FYB203	Germany’s Formycon (Munich, Germany)	Expected approval USA (2023) and Europe in (2025)
CHS-2020	Coherus BioSciences (Redwood City, CA, USA)	NA (preclinical)

Abbreviations: IND, investigational new drug application; NA, not approved; US FDA, United States Food and Drug Administration.

Table 3 Approved biosimilar of Avastin (bevacizumab)

Name	Company	Approval
ABP215 (Mvasi)	Amgen (Thousand Oaks, CA, USA) and Allergan (Dublin, Ireland)	US FDA (2017), EC (2017)
Cizumab	Hetero (Hyderabad, India)	DGCI (2016)
Bevacirel	Reliance Life Sciences (Mumbai, India)	DGCI (2016)
BCD-021	Biocad (Saint Petersburg, Russia)	Russian Regulatory Body (2015)
mAbxience	mAbxience (Madrid, Spain)	Argentina Regulatory Body (2016)
Krabeva	Biocon (Bangalore, India)	DGCI (2017)
Zybev	Zydus Cadila (Ahmedabad, India)	DGCI (2017)
Bevatas	Intas (Ahmedabad, India)	DGCI (2017)

Note: All the molecues approved after completion of Phase 3.

Abbreviations: DGCI, Drug Controller General of India; EC, European commission; US FDA, United States Food and Drug Administration.

Table 4 Approved biosimilar of Humira (adalimumab)

Name	Company	Approval
Cyltezo (US) (BI 695501)	Boehringer Ingelheim (Ingelheim am Rhein, Germany)	US FDA (2017), EMA (2017)
Imraldi (EU)/Hadlima (Korea) (SB5)	Samsung Bioepis (Biogen/Samsung)/Merck South Korea/USA	EMA (2016), Korea (2017)
Adfrar	Torrent Pharmaceuticals (Ahmedabad, India)	DGCI (2016)
Exemptia (ZRC3197)	Zydus Cadila (Ahmedabad, India)	DGCI (2014)
Amjevita (US)/Amgevita (EU)/Solymbic (EU) (ABP 501)	Amgen (Thousand Oaks, CA, USA)	US FDA (2016), EMA (2017)
Mabura	Hetero Drugs (Ahmedabad, India)	DGCI (2018)
GP2017	Sandoz (Basel, Switzerland)	EMA (2018)

Note: All the molecues approved after completion of Phase 3.

Abbreviations: DGCI, Drug Controller General of India; EMA, European Medical Agency; US FDA, United States Food and Drug Administration.