Table 1 Biosimilars approval status worldwide
Territory | Drug class | Drug name | Company | Status | Date |
|---|---|---|---|---|---|
USa | Recombinant glucagon | GlucaGen | Novo Nordisk | Approved | 1998 |
USa | Recombinant human growth hormone (rhGH) | Tev-tropin | Teva/Ferring | Approved | 2005 |
Australia | rhGH | Omnitrope | Sandoz | Approved | September 2004 |
USa | Hyaluronidase | Amphadase | Amphastar | Approved | October 2004 |
USa | rhGH | Omnitrope | Sandoz | Approved | May 2005 |
USa | Recombinant salmon calcitonin | Fortical Nasal Spray | Upsher-Smith Laboratories, Inc./UNIGENE | Approved | October 2005 |
USa | Hyaluronidase | Hydase | PrimaPharm | Approved | November 2005 |
USa | Recombinant human hyaluronidase | Hylenex | Baxter | Approved | December 2005 |
EU | rhGH | Omnitrope | Sandoz | Approved | April 12, 2006 |
EU | rhGH | Valtropin | BioPartners | Approved | April 24, 2006 |
EU | Interferon alpha | Alpheon | BioPartners | Refusal | June 28, 2006 |
EU | Recombinant human EPO (rhEPO) | Binocrit (epoetin alfa) | Sandoz | Approved | August 28, 2007 |
EU | rhEPO | Hexal (epoetin alfa) | Hexal | Approved | August 28, 2007 |
EU | rhEPO | Abseamed | Medice | Approved | August 28, 2007 |
EU | rhEPO | Silapo | Stada | Approved | December 8, 2007 |
EU | rhEPO | Retacrit | Hospira | Approved | December 18, 2007 |
EU | Insulin | Insulin Human Rapid Marvel | Marvel Life Sciences | Application withdrawn | January 24, 2008 |
EU | Insulin | Insulin Human Long Marvel | Marvel Life Sciences | Application withdrawn | January 24, 2008 |
EU | Insulin | Insulin Human 30/70 Mix Marvel | Marvel Life Sciences | Application withdrawn | January 24, 2008 |
EU | Recombinant human granulocyte colony stimulating factor (G-CSF) | Tevagrastim | Teva | Approved | September 15, 2008 |
EU | G-CSF | Ratiograstim | Ratiopharm | Approved | September 15, 2008 |
EU | G-CSF | Biograstim | CT Arzneimittel | Approved | September 15, 2008 |
Japan | EPO | EPO | Nippon Chemical Research | Application pending | Submitted November 2008 |
EU | G-CSF | Zarzio | Sandoz | Approved | February 6, 2009 |
EU | G-CSF | Filgrastim Hexal | Hexal | Approved | February 6, 2009 |
EU | Interferon beta-1a | Biferonex | BioPartners | Withdrawal | May 29, 2009 |
Japan | rhGH | Somatropin BS | Sandoz | Approved | June 2009 |
