For quite some time, providers, public and private payers, policy-makers, pharmacy benefit managers and patients have hoped the arrival of biosimilars would usher in a new era of competitive drug prices. However, as the U.S. market prepares to welcome its second biosimilar, Celltrion’s Inflectra, the future of biosimilars in this country remains unclear.

Barriers that could limit the market potential of biosimilars still exist. These include regulatory concerns pertaining to labelling, naming and interchangeability; reimbursement uncertainty; and insufficient education and evidence to support physician decision-making. In turn, some key stakeholders have adopted a more sceptical view of biosimilars’ short- and long-term impact on the healthcare industry, including their promise of cost savings.

Regardless of whether biosimilars ultimately offer stakeholders the financial relief they’ve been hoping for, one thing remains clear—the biosimilar pipeline is strong, creating both opportunities and inherent risks for manufacturers. This article provides an overview of the biosimilars market and some of its uncertainties. Included are strategies that both biosimilar and originator manufacturers should consider for success.