Biosimilars

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. They are safe and effective.

Biosimilars have no clinically meaningful difference from the reference product.

They are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biotherapeutic products. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are responsible for evaluating the applications for the biosimilar market.

ARTES offers a range of biosimilar-producing cell lines and processes for out-licensing and technology transfer. The cell lines listed are based on yeast, E. coli or mammalian expression systems.

Ready for transfer:
ProductManufactured in:Marketed in / Licensed toDeliverables
BivalirudinyeastRCB (pre-MCB) USP, DSP, IPC/QC
Follicle stimulating HormoneCHOMENA regionMCB/WCB USP, DSP IPC/QC
Full length factor VIIICHOMENA regionMCB/WCB USP, DSP IPC/QC
HirudinyeastMENA regionRCB (pre-MCB) USP, DSP, IPC/QC
Inter­feron alpha2ayeastIndia, MENA regionRCB (pre-MCB) USP, DSP, IPC/QC
Inter­feron alpha2byeastIndiaRCB (pre-MCB) USP, DSP, IPC/QC
Teriparatide (PTH 1 – 34)yeastMENA regionRCB (pre-MCB) USP, DSP, IPC/QC
Under development:
ProductManufactured in:Marketed in / Licensed toDeliverables
Anti-diabetic peptides
AspartE. coliRCB (pre-MCB) USP, DSP, IPC/QC
DetemiryeastRCB (pre-MCB) USP, DSP, IPC/QC
GlargineE. coliRCB (pre-MCB) USP, DSP, IPC/QC
InsulinyeastRCB (pre-MCB) USP, DSP, IPC/QC
LisproE. coliRCB (pre-MCB) USP, DSP, IPC/QC
LiraglutideyeastRCB (pre-MCB) USP, DSP, IPC/QC
SemaglutideyeastRCB (pre-MCB) USP, DSP, IPC/QC
Other products
G-CSFE. coliRCB (pre-MCB) USP, DSP, IPC/QC
Human Growth HormoneyeastRCB (pre-MCB) USP, DSP, IPC/QC
Human Serum AlbuminyeastRCB (pre-MCB) USP, DSP, IPC/QC
StaphylokinaseyeastRCB (pre-MCB) USP, DSP, IPC/QC

To receive a quote, please contact us at info(at)artes-biotechnology.com and provide the name of the biosimilar you are interested in. We will get back to you with a specific quote including delivery time and cost.