FDA Issues Complete Response Letter for Amgen’s Biosimilar of Roche’s Herceptin

The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Amgen regarding its biologics license application for a biosimilar to Roche’s Herceptin (trastuzumab), a cancer drug. Herceptin had 2017 global sales of CHF 7.01 billion ($7.5 billion).

Amgen is developing the biosimilar with Allergan. In December 2011, Amgen and Allergan (then Watson Pharmaceuticals) formed a pact to develop and commercialize four oncology antibody biosimilars on a worldwide basis. Under the agreement, Amgen has primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products.

“We will work closely with the FDA to bring this important medicine to patients in the US,” Amgen said in a company statement. “We do not expect this to impact our US launch plan.”

Teva Pharmaceutical industries and Celltrion, an Incheon, South Korea-based life-sciences company, are also advancing a Herceptin biosimilar. Celltrion received a Complete Response Letter over manufacturing issues in April 2018 regarding the BLA for a Herceptin biosimilar. In May 2018, Celltrion said it made progress in resolving its manufacturing issues and plans to resubmit the BLA for the Herceptin biosimilar to the FDA this month (June 2018).

In December 2017, the FDA approved Ogivri (trastuzumab-dkst), a biosimilar of Herceptin, from Mylan and Biocon, a Bangalore, India-based pharmaceutical company. Ogivri was approved for all indications included in the label of Herceptin, including for treating HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Source: Amgen

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