Clinical concerns of immunogenicity produced at cellular levels by biopharmaceuticals following their parenteral administration into human body.
Similar to the low molecular weight traditional drugs, biopharmaceuticals are capable of producing not only therapeutic effects but also side effects provided if the dose of these compounds exceeds certain concentration and/or if the exposure duration of these compounds at subtoxic doses is being lengthened. In addition, a major drawback of biopharmaceuticals is the risk of antibody formation. Following the administration of biopharmaceuticals into human body, the formation of antidrug-antibody (ADA) or neutralizing antibody and other general immune system effects (including allergy, anaphylaxis, or serum sickness) are of clinical concern regarding therapeutic efficacy and patient safety. For example, drug-induced neutralizing antibodies to erythropoietin (EPO) result in pure red cell aplasia, whereas drug-induced acquired anti-factor VIII antibodies worsen the pathology associated with hemophilia. Since most of the already developed or under development biopharmaceuticals are to some extent immunogenic, the regulatory agencies insist to conduct potential ADA formation during the drug development process itself. This review encompasses a short overview on the clinical concerns of immunogenicity produced at cellular levels by growth hormone, interferon-alpha, EPO, factor VIII, and factor IX following their parenteral administration into human body. Clinical concerns related to immunogenicity produced by the biosimilar versions of these drugs are also presented wherever possible.
Tamilvanan
Shunmugaperumal
S
Arulmigu Kalasalingam College of Pharmacy, Krishnankoil, Tamil Nadu, India. tamilvanan2k@yahoo.com
Raja
Natarajan Livingston
NL
Sa
Biswanath
B
Basu
Sanat Kumar
SK
D000818:Animals; D000917:Antibody Formation / Q000276:immunology*; D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D015195:Drug Design; D006801:Humans; D013810:Therapeutic Equivalency
D001688:Biological Products