. 2024 Jul 30;16(8):1013. doi: 10.3390/pharmaceutics16081013

Table 1.

European Pharmacopoeia biotherapeutics monographs [35]. Parentheses show the pharmacopeia monograph designation number.

Issued Monographs	New Monographs in Preparation
Alteplase for injection (1170) ^§ Calcitonin salmon (0471) Erythropoietin concentrated solution (1316) ^§ Etanercept (2895) Filgrastim concentrated solution (2206) Filgrastim injection (2848) * Follitropin (2285) Follitropin concentrated solution (2286) Glucagon, human (1635) Human coagulation factor IX (rDNA) powder for solution for injection (2994) * Human coagulation factor IX rDNA concentrated solution (2522) Human coagulation factor VIIa rDNA concentrated solution (2534) Human coagulation factor VIII rDNA (1643) ^§ Infliximab concentrated solution (2928) ^§ Insulin aspart (2084) Insulin glargine (2571) Insulin lispro (2085) Insulin preparations, injectable (0854) * Insulin, human (0838) Interferon alfa-2 concentrated solution (1110) Interferon gamma-1b concentrated solution (1440) Molgramostim concentrated solution (1641) Somatropin concentrated solution (0950) Somatropin (0951) Somatropin for injection (0952) * Somatropin solution for injection (2370) * Teriparatide (2829)	Alteplase concentrated solution (3197) Adalimumab (3147) Darbepoetin alfa (3009) Golimumab concentrated solution (3103) Golimumab injection (3187) * Human coagulation factor VIII (rDNA) concentrated solution (3105) Human coagulation factor VIII (rDNA) powder for injection (3106) * Human coagulation factor VIII (rDNA), B-domain deleted, concentrated solution (3107) Human coagulation factor VIII (rDNA), B-domain deleted, powder for injection (3108) * Insulin glargine injection (3129) * Pegfilgrastim (2889) Teriparatide injection (3130) * Ustekinumab (3165) Ustekinumab injection (3188) *

Issued Monographs

New Monographs in Preparation

Alteplase for injection (1170) ^§
Calcitonin salmon (0471)
Erythropoietin concentrated solution (1316) ^§
Etanercept (2895)
Filgrastim concentrated solution (2206)
Filgrastim injection (2848) *
Follitropin (2285)
Follitropin concentrated solution (2286)
Glucagon, human (1635)
Human coagulation factor IX (rDNA) powder for solution for injection (2994) *
Human coagulation factor IX rDNA concentrated solution (2522)
Human coagulation factor VIIa rDNA concentrated solution (2534)
Human coagulation factor VIII rDNA (1643) ^§
Infliximab concentrated solution (2928) ^§
Insulin aspart (2084)
Insulin glargine (2571)
Insulin lispro (2085)
Insulin preparations, injectable (0854) *
Insulin, human (0838)
Interferon alfa-2 concentrated solution (1110)
Interferon gamma-1b concentrated solution (1440)
Molgramostim concentrated solution (1641)
Somatropin concentrated solution (0950)
Somatropin (0951)
Somatropin for injection (0952) *
Somatropin solution for injection (2370) *
Teriparatide (2829)

Alteplase concentrated solution (3197)
Adalimumab (3147)
Darbepoetin alfa (3009)
Golimumab concentrated solution (3103)
Golimumab injection (3187) *
Human coagulation factor VIII (rDNA) concentrated solution (3105)
Human coagulation factor VIII (rDNA) powder for injection (3106) *
Human coagulation factor VIII (rDNA), B-domain deleted, concentrated solution (3107)
Human coagulation factor VIII (rDNA), B-domain deleted, powder for injection (3108) *
Insulin glargine injection (3129) *
Pegfilgrastim (2889)
Teriparatide injection (3130) *
Ustekinumab (3165)
Ustekinumab injection (3188) *

* Finished product monographs; ^§ under revision.