Fresenius Kabi vedolizumab biosimilar candidate has reached a key regulatory milestone. The company announced that the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted its applications for review.
The agencies accepted the Biologics License Application (BLA) and Marketing Authorisation Application (MAA). The submissions cover PB016, a proposed intravenous vedolizumab biosimilar candidate.
PB016 is used on the Entyvio®* (vedolizumab) lyophilized vial, which is meant to be administered intravenously. The medicine falls under the category of integrin receptor antagonists. Its indication is use among adults with moderate to severe ulcerative colitis and Crohn’s disease. The marketing authorization has been applied for by Polpharma Biologics S.A. On the other hand, the company has the exclusive right to market the medicine worldwide, except for the Middle East and North Africa.
“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”
Fresenius Kabi Expands Autoimmune Biosimilars Portfolio
The FDA and EMA acceptance of the review also supports the company’s strategy of growth in autoimmune biosimilars. Moreover, one of the goals of the company is to enhance access for patients to quality biologics. IBD, comprising Crohn’s disease and ulcerative colitis, has impacted millions of people across the globe. In America, there are about 2.4 million patients suffering from IBD. Europe has roughly 2.5-3 million patients.
Furthermore, there is an increasing trend of IBD worldwide because of the environment and industries. This disease is still chronic and can seriously impact the lives of those who are affected by it. The submissions of biosimilar vedolizumab have been made on the basis of a well-defined development program. Which measures the similarity between the biosimilar and its reference drug.
Biopharma is still a vital part of Fresenius #FutureFresenius agenda. The company keeps building an integrated biopharma business. It encompasses research, production, and worldwide marketing of products. Furthermore, the company integrates technology, production, and commercial know-how. Consequently, the company is working to maintain its global leadership position in the field of biosimilars.
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News Source: Businesswire.com
