title: Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective.
abstract: Over the last decades, billions have been spent and huge efforts have been taken in basic and clinical cancer research [CA Cancer J Clin63:11-30]. About a decade ago, the arms race between drugs and cancer cells reached a new level by introduction of tyrosine kinase inhibitors (TKI) into pharmacological anti-cancer therapy. According to their molecular mechanism of action, TKI in contrast to so-called "classic" or "conventional" cytostatics belong to the group of targeted cancer medicines, characterized by accurately fitting with biological structures (i.e. active centers of kinases). Numerous (partly orphan) indications are covered by this new class of substances. Approximately ten years after the first substances of this class of medicines were authorized, patent protection will end within the next years. The following article covers clinical meaning and regulatory status of anti-cancer TKI and gives an outlook to what is expected from the introduction of generic anti-cancer TKI.
authors: Federal Institute of Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, Bonn 53175, Germany. niels.eckstein@bfarm.de.
authors: Niels
authors: N
authors: Eckstein
authors: Lea
authors: L
authors: Röper
authors: Bodo
authors: B
authors: Haas
authors: Henrike
authors: H
authors: Potthast
authors: Ulrike
authors: U
authors: Hermes
authors: Christoph
authors: C
authors: Unkrig
authors: Frauke
authors: F
authors: Naumann-Winter
authors: Harald
authors: H
authors: Enzmann
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D019540:Area Under Curve; D004335:Drug and Narcotic Control; D016568:Drugs, Generic / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy*; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors / Q000378:metabolism; D015398:Signal Transduction
chemical_list: D000970:Antineoplastic Agents; D016568:Drugs, Generic; D047428:Protein Kinase Inhibitors; D011505:Protein-Tyrosine Kinases