The approval follows the agency’s recommendation made in February of this year.
As Biopharma-Reporter previously reported, Remsima has already been launched in several European markets and is also sold by Hospira, now a Pfizer company, under the name Inflectra.
“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” said Salomon Azoulay, MD, senior vice president and chief medical officer, Pfizer Global Established Pharma Business.
“As a leading global biologics company with several biosimilar products in our pipeline, we appreciate the significance of this milestone in developing a pathway for biosimilars to come to market in the U.S., and in helping advance their adoption in the healthcare system.”
The monoclonal antibody (mAb) is biosimilar to Janssen Biotech’s Remicade, which was first licensed in 1998 for several indications, including Crohn's, ulcerative colitis, and rheumatoid arthritis, among others.
Per the FDA’s release, the approval was based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data, all of which demonstrated that Inflectra was in fact biosimilar to Remicade.
“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,” said Jenny Alltoft, head of global biosimilars, Pfizer Inc. “Pfizer is proud to play a leading role in preparing the U.S. market for biosimilars. We are committed to bringing these important medicines to patients in the U.S. as quickly as possible.
According to Pfizer, Inflectra's launch timeline will depend on several factors, including marketplace dynamics and intellectual property considerations; however the company is preparing for its launch plans scheduled for 2016.