International Nonproprietary NameCompanyBase locationProduct's nameStatusStatus detailsLatin American commercialisation partner
RituximabDr. Reddy'sIndiaReditux / TidecronMarketMarketed in Chile, Ecuador, Peru and Paraguay. (1)CF Recalcine (Chile)
Western Pharmaceutical (Ecuador) (2)
Farmindustria (Peru) (2)
FAPASA (Paraguay)
ProbiomedMexicoKikuzubamMarketMarketed in Mexico. (3)NA
SandozGermanyGP2013ClinicalFL: Ph III started in Oct 2011.-
RA: Ph I/II started in Jan 2011.
CelltrionSouth KoreaCT-P10ClinicalFL: Phase III started in Dec 2011.OliMed
RA: Phase I started in Feb 2012.
Boehringer IngelheimGermanyBI 695500ClinicalRA: Ph III started on Sept 2012.-
FL: Ph III started in Jan 2013.
PfizerUSAPF-05280586ClinicalRA: Ph I/II started in March 2012.-
MSDUSAMK-8808ClinicalRA: Ph I started in July 2011.-
Samsung BioepisSouth KoreaSAIT-101ClinicalRA: Ph I/III in RA stopped in Oct 2012. (4)-
MabionPolandMabionCD20Clinical-Human Bioscience (5)
Grupo InsudArgentinaUnknownClinicalDLBCL: Ph III planned in Argentina.NA
BiocadRussiaBCD-020ClinicalFL: Ph II/III started in Sept 2011.Agreement of intent on TT to Biocad Brazil signed on Feb 2013.
RA: Ph III started in Dec 2012.
BiosidusArgentinaUnknownR&D-NA
Bio-ManguinhosBrazilUnknownIntentions-NA
FUNEDBrazilUnknownIntentions-NA
Etanercept (6)Shanghai CP GoujianChinaEtanarMarketMarketed in Colombia.LaFrancol
ReumatoceptClinicalRA: Ph III planned to start in Aug 2013.EMS
Grupo InsudArgentinaUnknownR&D-NA
Amega BiotechArgentinaUnknownR&D-NA
BiosidusArgentinaUnknownR&D-NA
InfliximabCelltrionSouth KoreaCT-P13FiledFiled for approval globally in 2012. (7)OliMed
TrastuzumabCelltrionSouth KoreaCT-P06ClinicalBC: Ph III completed in Dec 2011.OliMed
BiocadRussiaBCD-022ClinicalBC: Ph III started in Oct 2012.Agreement of intent on TT to Biocad Brazil signed on Feb 2013.
Grupo InsudArgentinaUnknownR&D-NA
Bio-ManguinhosBrazilUnknownIntentions-NA
BevacizumabBiocadRussiaBCD-021ClinicalNSCLC: Ph III started in Oct 2012.Agreement of intent on TT to Biocad Brazil signed on Feb 2013.
Grupo InsudArgentinaUnknownR&D-NA
UndisclosedHetero GroupIndia5 mAbsIntentions --
Bionovis (8)Brazil7 mAbsIntentions -NA
Orygen (9)Brazil7 mAbsIntentions -NA
LaFrancol Colombia UnknownIntentions -NA
ProCapsColombiaUnknownIntentions Partnership with BiosidusNA
BC: Breast cancer; DLBCL: Diffuse large B-cell lymphoma; FL: Follycular Lymphoma; NA: Not applicable; NSCLC: Non-Small Cell Lung Cancer; RA: Rheumatoid Arthritis; TT: Technology transfer
(1) Filed also in Colombia and rejected twice during 2012.
(2) Western Pharmaceutical and Farmindustria are subsidiaries of CF Recalcine.
(3) Filed also in Colombia and recommended not to be approved on Dec 2012.
(4) Partnership with MSD, established on February 2013, suggests potential restart / continuation of trial.
(5) Partnership with Human Bioscience established on July 2012 for commercialization in Colombia, Venezuela, Ecuador and Peru.}
(6) Etanercept is a fusion protein, not a mAb
(7) Marketed in South Korea since September 2012.
(8) Group of companies integrated by: Aché, EMS, Uniao Química, Hypermarcas.
(9) Group of companies integrated by: Eurofarma, Cristalia, Biolab (Libbs also formed part of this group but left it on Jan 2013)
