title: NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives.
abstract: Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.
authors: Andrew D
authors: AD
authors: Zelenetz
authors: Islah
authors: I
authors: Ahmed
authors: Edward Louis
authors: EL
authors: Braud
authors: James D
authors: JD
authors: Cross
authors: Nancy
authors: N
authors: Davenport-Ennis
authors: Barry D
authors: BD
authors: Dickinson
authors: Steven E
authors: SE
authors: Goldberg
authors: Scott
authors: S
authors: Gottlieb
authors: Philip E
authors: PE
authors: Johnson
authors: Gary H
authors: GH
authors: Lyman
authors: Richard
authors: R
authors: Markus
authors: Ursula A
authors: UA
authors: Matulonis
authors: Denise
authors: D
authors: Reinke
authors: Edward C
authors: EC
authors: Li
authors: Jessica
authors: J
authors: DeMartino
authors: Jonathan K
authors: JK
authors: Larsen
authors: James M
authors: JM
authors: Hoffman
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D016568:Drugs, Generic / Q000191:economics / Q000627:therapeutic use; D005060:Europe; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy; D014481:United States; D014944:World Health Organization
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic