J Natl Compr Canc Netw. 2011 Sep;9 Suppl 4:S1-22. doi: 10.6004/jnccn.2011.0136.
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.
生物制剂是肿瘤治疗的重要手段。随着旧生物制剂的专利开始到期，美国正在为类似生物制剂（生物类似药）的审批开发简化的监管程序，这为安全、合理地将生物类似药纳入癌症患者的临床实践提出了重要的考虑因素。生物类似药有降低生物制剂成本的潜力，而生物制剂通常是肿瘤治疗的高成本组成部分，这是 2009 年《生物制品价格竞争与创新法案》（Biologics Price Competition and Innovation Act）的推动因素，该法案是 2010 年《平价医疗法案》（Affordable Care Act）的一部分。2011 年 3 月，NCCN 组建了一个工作组，由 NCCN 成员机构和其他组织的思想领袖组成，就医疗保健提供者和其他利益相关者在将生物类似药纳入医疗实践中面临的挑战提供指导。该工作组确定了与生物类似药相关的挑战，包括医疗保健提供者的知识、替代实践、药物警戒、命名和产品跟踪、覆盖范围和报销、在标签外使用以及批准的数据要求。
