In 2010 Congress enacted the Biologics Price Competition and Innovation Act with the goal of providing an official regulatory approval pathway (titled 351[k]) for generic replicas of an emerging class of therapeutics known as biologics, or biosimilars. A key advantage of biosimilars is their reduced cost compared with the originator product, resulting in increased access for patients. Yet, only 4 biosimilars are currently available for sale in the United States, despite the Food and Drug Administration (FDA) receiving at least 23 separate 351(k) submissions seeking approval and green-lighting 12 for commercialization. Stringent FDA guidelines/protocols governing biosimilar development, as well as the bevy of intellectual property defense tactics available to US innovator manufacturers, are among the primary factors hindering biosimilar approval efforts to date. In their article, Michael Kuehn, RPh, and Jay Galli aim to contextualize one of the key dynamics impeding biosimilar utilization in the United States—manufacturer contracting—and provide additional insights into payer perceptions of biosimilars from a financial perspective using simulation models (page 36). Their analysis sets the stage for a discussion on opportunities and challenges facing oncology biosimilars.
Chimeric antigen receptor (CAR) T-cell therapy has the potential to transform cancer treatment. The initial clinical trials for the FDA-approved cellular therapies were conducted in academic centers, but the future administration of these therapies and the future conduct of clinical trials need not be restricted to this setting. For many oncologists, the preparation to administer CAR T-cell products is similar to the model used to prepare for outpatient stem cell and bone marrow transplant programs. Utilizing their knowledge gained from working with centers that have been approved to administer the available CAR T-cell therapies, Sandy Smith, RN, MSN, AOCN, and James Essell, MD, provide a detailed overview of how facilities can self-assess and prepare to deliver CAR T-cell infusion (page 42). Before cellular therapies become standard outpatient procedures, many critical issues will need to be addressed, including coordination of care, availability of specific resources, education of patients and caregivers, and toxicity management—both clinical and financial toxicity.
We are excited to announce the addition of a new section provided by the Community Oncology Alliance (COA) called the “COA Viewpoint” (page 20). COA and JCP have joined in collaboration to keep JCP readers informed about news and research in the community oncology field, including available programs, research, and resources.