Characteristics of the 6 recombinant FVIII products commercialized worldwide
| Product . | Manufacturer . | Distributor . | Brand name . | Generation . | Production cell line . | Protein length . | Human or animal proteins in fermentation process . | Albumin as stabilizer . | Marketing authorization dates in EU . |
|---|---|---|---|---|---|---|---|---|---|
| A | Baxter Bioscience | Baxter Healthcare | Recombinate | 1 | CHO | Full | Yes | Yes | June 17, 1993 |
| Aventis Behring | Bioclate | ||||||||
| B | Bayer HealthCare | Bayer HealthCare | Kogenate | 1 | BHK | Full | Yes | Yes | June 15, 1994 |
| Aventis Behring | Helixate | ||||||||
| C | Wyeth Pharmaceuticals | Wyeth Pharmaceuticals | ReFacto | 2 | CHO | B-domain deleted | Yes | No | April 13, 1999 |
| D | Bayer HealthCare | Bayer HealthCare | Kogenate FS/Bayer | 2 | BHK | Full | Yes | No | August 4, 2000 |
| CSL Behring | Helixate NexGen | ||||||||
| E | Baxter Bioscience | Baxter Healthcare | Advate | 3 | CHO | Full | No | No | March 2, 2004 |
| F | Pfizer | Pfizer | ReFacto AF | 3 | CHO | B-domain deleted | No | No | April 15, 2009 |
| Xyntha (used outside the EU) |
| Product . | Manufacturer . | Distributor . | Brand name . | Generation . | Production cell line . | Protein length . | Human or animal proteins in fermentation process . | Albumin as stabilizer . | Marketing authorization dates in EU . |
|---|---|---|---|---|---|---|---|---|---|
| A | Baxter Bioscience | Baxter Healthcare | Recombinate | 1 | CHO | Full | Yes | Yes | June 17, 1993 |
| Aventis Behring | Bioclate | ||||||||
| B | Bayer HealthCare | Bayer HealthCare | Kogenate | 1 | BHK | Full | Yes | Yes | June 15, 1994 |
| Aventis Behring | Helixate | ||||||||
| C | Wyeth Pharmaceuticals | Wyeth Pharmaceuticals | ReFacto | 2 | CHO | B-domain deleted | Yes | No | April 13, 1999 |
| D | Bayer HealthCare | Bayer HealthCare | Kogenate FS/Bayer | 2 | BHK | Full | Yes | No | August 4, 2000 |
| CSL Behring | Helixate NexGen | ||||||||
| E | Baxter Bioscience | Baxter Healthcare | Advate | 3 | CHO | Full | No | No | March 2, 2004 |
| F | Pfizer | Pfizer | ReFacto AF | 3 | CHO | B-domain deleted | No | No | April 15, 2009 |
| Xyntha (used outside the EU) |
EU, European Union.