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| 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