CHMP Adopts Positive Opinions on BI’s CYLTEZO® and Samsung Bioepis’s ONTRUZANT®

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On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding a biosimilar product for which the company is seeking European marketing approval.

BI’s press release announced the positive CHMP opinion for Cyltezo®, a proposed biosimilar of Humira® (adalimumab), for the treatment of multiple chronic inflammatory diseases in adults and children.  According to BI: “The decision of the European Commission on the approval is expected in the fourth quarter of 2017.”  The press release further notes that BI received FDA approval for Cyltezo® on August 25, 2017, but that Cyltezo® is not commercially available in the US at this time and is the subject of pending patent litigation against AbbVie.

Samsung Bioepis’s press release indicated that the CHMP has adopted a positive opinion for Ontruzant®, a proposed biosimilar of Herceptin® (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.  According to the press release: “The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide on the grant of a marketing authorization for ONTRUZANT®.  If a marketing authorization is granted by the EC, ONTRUZANT® will be commercialized in the European Union by MSD, which is known as Merck in the United States and Canada.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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