Biosimilar
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: | |||
|---|---|---|---|
| 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 |
We also have a selection of ready-to-use cell lines and processes for enzymes or vaccines.
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.