The U.S. Biosimilar Market: Ongoing Policy Challenges Among Key Health Care Stakeholders
Creators: name: Lynch, Christine
Publisher: name: The University of North Carolina at Chapel Hill University Libraries
Year: 2017

description: US biologic pharmaceuticals are currently the most expensive medicines on the market. Biologic products are complex protein, vaccines, or living entities (e.g. cells) derived from living cell recombinant DNA technology or natural sources such as human tissue. Manufacturing biologics typically requires rigorous processes to reduce variability and maintain the structural integrity of the compound (US Food and Drug Administration, 2016) Because of the strong association between compound structure and therapeutic function, small structural changes in chemical moiety can directly affect and clinical properties of the final product. The U.S. biosimilar market is comprised of large molecule biologic compounds approved as “generic” versions of approved large molecule biologic medications. Similar to generic small molecule products, biosimilars are intended to reduce health care cost by creating competition in the biologic marketplace through offering lower priced alternative products. The potential direct savings on biologic spending in the U.S. has been estimated at 44.2 billion from 2014 through 2024 (Singh, 2015). Unlike small molecule drugs that face generic competition following patent expiration, biologic (large molecule) medicines lack any price competition, thus higher prices extend long after patent exclusivity protection. The first biosimilar approval pathway to provide lower cost alternatives to biologics was developed by European Union (EU) regulators, the European Medicines Agency (EMA) in 2004. In addition to providing alternative biologic medication at a reduced cost, biosimilars have been implemented into medical society guideline recommendations, thus influencing new standards of medical practice. An early example of biosimilar guideline updates includes the European Organization for Research and Treatment of Cancer (EORTC) consortium recommendation to include the biosimilar filgrastim, a colony stimulator factor used to reduce the chemotherapy-induced febrile neutropenia associated with cancer treatment in 2010. Filgrastim was incorporated as first-line cancer treatment within both EORTC guidelines and National Institute for Health and Care Excellence (NICE) recommendations. This action was in response to improved cost-effectiveness of the biologic originator product filgrastim (G-CSF) Subsequent to biosimilar guideline inclusion, filgrastim Drug utilization increased by 104% from January 2009 to January 2014, thereby enabling more patients to access treatment at earlier stages within chemotherapy cycles. Statutory regulation of biosimilars within the U.S. followed EU biosimilar regulation, enacted as part of the Patient Protection and Affordable Care Act (ACA) in 2010 (FDA, 2016). As biosimilar research development reaches its seventh year within the U.S., four biosimilar agents have received FDA approval. Comparatively, following the first two biosimilar therapies approved by the EMA in 2006, over 20 biosimilar products are approved for use within the EU (IMS Institute for Healthcare Informatics, 2016). Projections regarding the clinical and economic impact of biosimilar products have been met with controversy regarding biosimilar drug safety, provider perceived differences in drug efficacy, and complications within reimbursement and coverage within a privatized, for-profit, health care system. Additionally, U.S. patent litigation and disputes associated with the regulatory processes (e.g. naming convention, product interchangeability studies, unmet scheduled guidance meetings with the FDA and manufacturers) continue to stall successful implementation and access to biosimilar products. The purpose of this paper is to provide perspective and an objective assessment of key policy issues facing key health care stakeholders in the U.S. concerning drug safety and efficacy, drug cost and reimbursement policies set by payers, and the statutory regulation of interchangeability and substitution designation (of biosimilars with already approved reference biologic products). Additionally, gaps in both patient and prescriber education in understanding the potential benefit of competitive biosimilar products present barriers to utilization as heeded by European healthcare analysts. “Since their first introduction in the EU, biosimilar medicines increased patient access by 44% in the EU-5 countries between 2006 and 2014.” –Carol Lynch, Global Health of Biopharmaceuticals at Sandoz and Chair of the Biosimilars Medicines Group (Medicines for Europe, 2016) As U.S. utilization of biosimilars is assessed, we may glean insight from the EU comparative biosimilar market initiated in 2005 regarding best practices, barriers to biosimilar utilization, and overall patient (and population) health improvements associated with increased access to effective and costly biologic medicines.