Other Biosimilars and Copy Biologicals**
Low Cost EPO for the EU Market : $1.80 per 1,000 IU vial CIF blank labels and $3.00 per 2000 IU vial CIf blank labels
Neulasta (PEG Filgrastim) Biosimilar Registered in 2 countries with pK studies, recombinant plant is EU inspected for FI and FII, ready for EU development as MAA biosimilar
Beta Interferon 1a Serum -free process, have clinical supplies, biosimilar to Rebif.
Insulin 100 IU/ml in 1.5 & 3 ml Cartridges Approved in Brasil and Mexico as biosimilar. USA Phase III, USA. EU filing and launch.
Lantus (insulin glargine) 100 IU/ml 3ml cartridges IND in late 2010, expected launch 2012, if no litigation. Otherwise 2014.
Filgrastim G-CSF - Phase III noninferiority, n=600, filing USA and EU
G-CSF for Less Regulated Markets - finished product in vials are produced in Germany for export. The price is EUR 12.00 per 300 mcg vial
Imiglucerase (Cerezyme) 200 and 400 IU/vial: Phae III studies in Brazil; USA NDA filing in for 2013 launch. EU biosimilar Filing and launch. Protocol available for SAP in USA
Beta Interferon 1a: completed n=339 placebo controlled study over 2 years
Beta Interferon 1b: scaling up, MCB to be transferred to an EU cGMP facility; filing MAA via CP as an EU biosimilar product
Enoxaparin pre-filled syringes: launched in Latin Amnerica with 3 clinical trials 60 patients, BE studies, compliant to EU biosimilar law
Etanercept vials filled in China: approval and CPP, ready for license and distribution in Latin America and ROW
