From #Merck:

Merck Announces FDA Accepts Samsung Bioepis’ Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade

First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck

Monday, May 23, 2016 7:50 pm EDT

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KENILWORTH, N.J. – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.

This BLA is the first application filed in the United States by Samsung Bioepis as part of its partnership with Merck to offer biosimilar alternatives to existing biologic medicines. The application seeks approval for use in all therapeutic indications currently approved for Remicade for which marketing exclusivity has expired.

“The acceptance of this biosimilar application by the U.S. FDA is an exciting milestone in the progression of our collaboration with Samsung Bioepis,” said Dora Bibila, general manager, Merck Biosimilars. “If approved, SB2 would offer an important therapeutic option to help meet the needs of U.S. physicians, patients and the healthcare system in the treatment of certain serious inflammatory diseases.”

About the Merck and Samsung Bioepis collaboration

Merck and Samsung Bioepis announced in February 2013 a development and commercialization agreement under which Merck will commercialize multiple biosimilar candidates in certain partnered territories. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Merck has full responsibility for commercialization of approved products resulting from the agreement.

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn. 

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