a) Name of the product: Interleukin 2 Recombinant
Brand name(Mfg. Co.) : Proleukin (Chiron/ Cetus)
Therapeutic Indication: For metastatic renal cancer. A protein drug through which immune cells communicate with each other.
b) Name of the product: Interferon Alpha 2a, Recombinant
Brand name (Mfg. Co.) : Roferon A (Hoffman LaRoche)
Therapeutic Indication: For hairy cell leukaemia; AIDS related Kaposi’s sarcoma; Antiviral activity, especially against RNA viruses; enhances the targeting of monoclonal antibody tethered cytotoxic drugs to cancer cells.
Mechanism of action: Interferon alpha binds to type I interferon receptors (IFNAR1 and IFNAR2c) which, upon dimerization, activate two Jak (Janus kinase) tyrosine kinases (Jak1 and Tyk2). These transphosphorylate themselves and phosphorylate the receptors. The phosphorylated INFAR receptors then bind to Stat1 and Stat2 (signal transducers and activators of transcription)which dimerize and activate multiple (~100) immunomodulatory and antiviral proteins. Interferon alpha binds less stably to type I interferon receptors than interferon beta.
c) Name of the product: Interferon Alfa 2b, Recombinant
Brand name (Mfg. Co.) : Intron A (Hoffman LaRoche)
Therapeutic Indication: For hairy cell leukaemia; AIDS related Kaposi’s sarcoma; chronic hepatitis types B and C; Condylomata acuminata.
d) Name of the product: Somatropin
Brand name (Mfg. Co.) : Humatrope(Eli-Lilly); Protropin (Genentach)
Therapeutic Indication: Identical to human pituitary derived somatropin; for human growth hormone deficiency in children.
Mechanism of action: hGH binds to the human growth hormone receptor (GHR). Upon binding, hGH causes dimerization of GHR, activation of the GHR-associated JAK2 tyrosine kinase, and tyrosyl phosphorylation of both JAK2 and GHR. These events recruit and/or activate a variety of signaling molecules, including MAP kinases, insulin receptor substrates, phosphatidylinositol 3' phosphate kinase, diacylglycerol, protein kinase C, intracellular calcium, and Stat transcription factors. These signaling molecules contribute to the GH-induced changes in enzymatic activity, transport function, and gene expression that ultimately culminate in changes in growth and metabolism.
e) Name of the product: Calcitonin
Brand name(Mfg. Co.) : Cibacalcin (Ciba); Miacalcin (Sandoz) (Rhone Poulenc Porer)
Therapeutic Indication: To decrease osteoelastic activity there by inhibiting the movement of bone to its from bone to the blood; also decreases renal tubular secretion of calcium.
f) Name of the product: Alteplase Recombinant
Brand name(Mfg. Co.) : Actirase (Genentech)
Therapeutic Indication: For acute myocardial infarction; Pulmonary embolism.
iv. Blood clotting Proteins
g) Name of the product: Antihemophilic factor
Brand name(Mfg. Co.) : Profilate(Alpha) Hemofil T(Hyland); KoGENate(Miles); Recombinant (Baxter)
Therapeutic Indication: For the management and control of severe hemorrhage in the patient with hemophilia A.
v. Immunoactive Drugs
h)Name of the product: Muromonab CD3
Brand name(Mfg. Co.) : Orthcloue OKT3(Ortho)
Therapeutic Indication: For acute alograft and cardiac transplant patients.
i) Name of the product: Hepatitis B vaccine
Brand name(Mfg. Co.) : Engerix B (Smith Kline Beecham)
Therapeutic Indication: Hepatitis B prevention. Comprise of highly specific antibodies that more or less act as ‘magic bullets’
Name of the product: Human Insulin
vii. Anti-HIV Agents /HIV Fusion Inhibitors
j) Name of the product: Enfuvirtide
Brand name(Mfg. Co.) : Fuzeon (Roche Pharmaceuticals)
Therapeutic Indication:Enfuvirtide is an antiretroviral drug used in combination therapy for the treatment of HIV-1/AIDS.
Mechanism of Action: Enfuvirtide is a biomimetic peptide that was rationally designed to mimic components of the HIV-1 fusion machinery and displace them, preventing normal fusion.
It binds to the first heptad-repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational changes required for the fusion of viral and cellular membranes. It works by disrupting the HIV-1 molecular machinery at the final stage of fusion with the target cell, preventing uninfected cells from becoming infected.
For more about: Approved Biotechnology Drugs