title: Biosimilars lining up to compete with Herceptin--opportunity knocks.
abstract: Trastuzumab is a monoclonal antibody developed by Genentech as a treatment for breast cancer and gastric cancer when the cancer cells overexpress HER2, a membrane-bound receptor activated by epidermal growth factor. Now marketed by Roche under the trade name Herceptin, trastuzumab has been readily adopted as treatment for some of the most invasive types of breast cancer. The cost for Herceptin is over $50,000 for a full course of treatment. With the development of regulatory pathways for biosimilar products, and the imminent expiry of patents covering Herceptin, several companies have developed biosimilar trastuzumab products. As biosimilar manufacturers look for opportunities to market biosimilar trastuzumab products, Roche has positioned itself to protect its market by developing additional anti-HER2 products complementary to Herceptin. The advent of competition from biosimilars should bring some opportunity for cost savings for patients, as well as incentive for continued advancement in development of better treatments to fight breast cancer.
authors.affiliation: Duane Morris LLP , 190 S LaSalle St, Suite 3700, Chicago, IL 60603 , USA +1 312 499 6770 ; kmnelson@duanemorris.com.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Nelson
authors.forename: Patrick C
authors.initials: PC
authors.lastname: Gallagher
mesh_terms: D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000737:chemistry / Q000191:economics / Q000494:pharmacology*; D000970:Antineoplastic Agents / Q000737:chemistry / Q000191:economics / Q000494:pharmacology*; D059451:Biosimilar Pharmaceuticals / Q000737:chemistry / Q000191:economics / Q000494:pharmacology*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics; D005260:Female; D006801:Humans; D010330:Patents as Topic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000187:drug effects / Q000235:genetics; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: FDA; Herceptin®; biologics (biological drug products); biosimilars; monoclonal antibodies; patents; trastuzumab