Since April, two other biosimilars have received approval: Erelzi, a biosimilar to etanercept (Enbrel), and Amjevita, a biosimilar to adalimumab (Humira).
The American College of Rheumatology (ACR) has stated, “The FDA considers a product to be ‘biosimilar’ to a reference product if it is shown to have no clinically meaningful differences with respect to safety, potency, and purity.”
At the time of Inflectra’s approval, Douglas White, MD, PhD, of the ACR’s Committee on Rheumatologic Care told MedPage Today, “The ACR is hopeful that biosimilars will help reduce the cost of biologics and thus improve patient access to these complex and lifesaving drugs.”
