Pharmaceuticals, biologics and biopharmaceuticals - Pharmaceutical Biotechnology: Concepts and Aapplications - page 11

Table 1.6 Summary categorization of biopharmaceuticals approved for general medical use in the
EU and/or USA by 2006

Product type Examples No. approved Refer to

Blood factors Factors VIII and IX 8 Chapter 12

Thrombolytic agents tPA 6 Chapter 12

Hormones Insulin, GH,

gonadotrophins

33 Chapter 11

Haematopoietic growth
factors

EPO, CSFs 8 Chapter 10

Interferons IFN-α, -β, -γ 16 Chapter 8

Interleukin-based
products

IL-2 3 Chapter 9

Vaccines Hepatitis B-surface

antigen

20 Chapter 13

Monoclonal antibodies Various 30 Chapter 13

Nucleic acid based Antisense and aptamer 2 Chapter 14

Additional products Tumour necrosis factor

(TNF), therapeutic
enzymes

18 Va r ious chapters

At least 1000 potential biopharmaceuticals are currently being evaluated in clinical trials, al-
though the majority of these are in early stage trials. Vaccines and monoclonal antibody-based
products represent the two biggest product categories. Regulatory factors (e.g. hormones and

Table 1.7 Some recombinant (r) biopharmaceuticals recently approved for veterinary application in the EU

Product Company Indication

Vibragen Omega (r-feline
interferon omega; IFN-ω)

Virbac Reduction of mortality/clinical

symptoms associated with
canine parvovirus

Fevaxyl Pentafel (combination
vaccine containing r-feline
leukaemia viral antigen as one
component)

Fort Dodge Laboratories Immunization of cats against

various feline pathogens

Porcilis porcoli (combination
vaccine containing r- E. coli
adhesins)

Intervet Active immunization of sows

Porcilis AR-T DF (combination
vaccine containing a
recombinant modifi ed toxin
from Pasteurella multocida )

Intervet Reduction in clinical signs of

progressive atrophic rhinitis in
piglets

Porcilis pesti (combination vaccine
containing r-classical swine
fever virus E 2 subunit antigen)

Intervet Immunization of pigs against

classical swine fever

Bayovac CSF E2 (combination
vaccine containing r-classical
swine fever virus E 2 subunit
antigen)

Intervet Immunization of pigs against

classical swine fever