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 US Food and Drug Administration (FDA) are responsible for evaluating the applications to the biosimilars market.
ARTES offers a range of biosimilar producing cell lines and processes for out-licensing and technology transfer. The listed cell lines are based on yeast, E. coli or mammalian expression system.
| Ready for transfer: | |||
|---|---|---|---|
| Product | Manufactured in: | Marketed in / Licensed to | Deliverables |
| Bivalirudin | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Follicle stimulating Hormone | CHO | MENA region | MCB/WCB USP, DSP IPC/QC |
| Full length factor VIII | CHO | MENA region | MCB/WCB USP, DSP IPC/QC |
| Hirudin | yeast | MENA region | RCB (pre-MCB) USP, DSP, IPC/QC |
| Interferon alpha2a | yeast | India, MENA region | RCB (pre-MCB) USP, DSP, IPC/QC |
| Interferon alpha2b | yeast | India | RCB (pre-MCB) USP, DSP, IPC/QC |
| Teriparatide (PTH 1 – 34) | yeast | MENA region | RCB (pre-MCB) USP, DSP, IPC/QC |
| Under development: | |||
|---|---|---|---|
| Product | Manufactured in: | Marketed in / Licensed to | Deliverables |
| Anti-diabetic peptides | |||
| Aspart | E. coli | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Detemir | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Glargine | E. coli | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Insulin | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Lispro | E. coli | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Liraglutide | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Semaglutide | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Other products | |||
| G-CSF | E. coli | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Human Growth Hormone | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Human Serum Albumin | yeast | RCB (pre-MCB) USP, DSP, IPC/QC | |
| Staphylokinase | yeast | RCB (pre-MCB) USP, DSP, IPC/QC |
To obtain a quote, please contact us at info(at)artes-biotechnology.com indicating name of the vaccine of interest to you. We will revert to you with a dedicated offer specifying delivery times and cost.