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Merck's Partner Gets FDA Nod for Herceptin Biosimilar

Merck & Co Inc. MRK announced that its partner, Samsung Bioepis Co., Ltd received FDA approval for Ontruzant, a biosimilar to Roche Holding AG's RHHBY breast cancer treatment, Herceptin. Ontruzant is approved for the treatment of patients with HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

Ontruzant is Samsung Bioepis’ first oncology biosimilar to receive FDA approval and will be marketed and distributed in the United States by Merck. Ontruzant was also approved by the European Commission (EC) in November 2017.

Shares of Merck have increased 27.7% in the past year compared with the industry’s growth of 2.5%.

We remind investors that last month, the FDA approved Herzuma, which is another biosimilar of Herceptin for the treatment of patients with HER2-overexpressing breast cancer. Herzuma is co-developed by Celltrion and Teva Pharmaceutical Industries TEVA.

Merck is looking toward biosimilars to drive long-term growth. The biosimilars market represents huge commercial opportunity. Merck has an agreement with Samsung Bioepis for the development and commercialization of several pre-specified and undisclosed biosimilar candidates.

The companies received a tentative U.S. approval for the biosimilar version of Sanofi’s SNY Lantus (MK-1293) in July 2017. The Lantus biosimilar is already approved in the EU. Meanwhile, the companies launched a biosimilar version of blockbuster RA drug, Remicade in the United States in July 2017.

Zacks Rank

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

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