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

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.”