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

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in response to a biologics license application (BLA) for the company’s proposed biosimilar to Roche’s Herceptin (trastuzumab), a drug for treating HER2-positive breast and gastric cancers. Herceptin had global 2017 sales of CHF 7.01 billion ($7.5 billion).

In the CRL, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer says it is working with the FDA to address the contents of the letter.

Earlier this month in April 2018, Teva Pharmaceutical Industries and Celltrion, an Incheon, South Korea-based life-sciences company, received a CRL from the FDA over manufacturing issues regarding the companies’ BLA for proposed biosimilars of Herceptin and rituximab, which references Roche’s Rituxan.

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: Pfizer

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