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Current development and marketing of biosimilar monoclonal antibodies in Latin America

An in-depth table of biosimilar products in the region

Read an article discussing the biosimilars markets in Latin America

International Nonproprietary Name Company Base location Product's name Status Status details Latin American commercialisation partner
Rituximab Dr. Reddy's India Reditux / Tidecron Market Marketed in Chile, Ecuador, Peru and Paraguay. (1) CF Recalcine (Chile)
Western Pharmaceutical (Ecuador) (2)
Farmindustria (Peru) (2)
FAPASA (Paraguay)
Probiomed Mexico Kikuzubam Market Marketed in Mexico. (3) NA
Sandoz Germany GP2013 Clinical FL: Ph III started in Oct 2011. -
RA: Ph I/II started in Jan 2011.
Celltrion South Korea CT-P10 Clinical FL: Phase III started in Dec 2011. OliMed 
RA: Phase I started in Feb 2012.
Boehringer Ingelheim Germany BI 695500 Clinical RA: Ph III started on Sept 2012. -
FL: Ph III started in Jan 2013.
Pfizer USA PF-05280586 Clinical RA: Ph I/II started in March 2012. -
MSD USA MK-8808 Clinical RA: Ph I started in July 2011. -
Samsung Bioepis South Korea SAIT-101 Clinical RA: Ph I/III in RA stopped in Oct 2012. (4) -
Mabion Poland MabionCD20 Clinical - Human Bioscience (5)
Grupo Insud Argentina Unknown Clinical DLBCL: Ph III planned in Argentina. NA
Biocad Russia BCD-020 Clinical FL: 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.
Biosidus Argentina Unknown R&D - NA
Bio-Manguinhos Brazil Unknown Intentions - NA
FUNED Brazil Unknown Intentions - NA
Etanercept (6) Shanghai CP Goujian China Etanar Market Marketed in Colombia. LaFrancol
Reumatocept Clinical RA: Ph III planned to start in Aug 2013. EMS
Grupo Insud Argentina Unknown R&D - NA
Amega Biotech Argentina Unknown R&D - NA
Biosidus Argentina Unknown R&D - NA
Infliximab Celltrion South Korea CT-P13 Filed Filed for approval globally in 2012. (7) OliMed
Trastuzumab Celltrion South Korea CT-P06 Clinical BC: Ph III completed in Dec 2011. OliMed
Biocad Russia BCD-022 Clinical BC: Ph III started in Oct 2012. Agreement of intent on TT to Biocad Brazil signed on Feb 2013.
Grupo Insud Argentina Unknown R&D - NA
Bio-Manguinhos Brazil Unknown Intentions - NA
Bevacizumab Biocad Russia BCD-021 Clinical NSCLC: Ph III started in Oct 2012. Agreement of intent on TT to Biocad Brazil signed on Feb 2013.
Grupo Insud Argentina Unknown R&D - NA
Undisclosed Hetero Group India 5 mAbs Intentions  - -
Bionovis (8) Brazil 7 mAbs Intentions  - NA
Orygen (9) Brazil 7 mAbs Intentions  - NA
LaFrancol  Colombia  Unknown Intentions  - NA
ProCaps Colombia Unknown Intentions  Partnership with Biosidus NA

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)

The table was compiled by Miguel Ferreira, Areli Lopez, Gabriel Munoz and Patrick Romano of Deallus Consulting.

Miguel is a regional consultant - Iberia and LatAm, Areli is an associate, Gabriel is consultant and Patrick is a partner and head of EMEA and Latin America. 

Read an article discussing the biosimilars markets in Latin America

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