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The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
On May 2, 2018, Novartis’s Sandoz announced that it received a complete response letter (CRL) from FDA in response to the biologics license application (BLA) for the company’s proposed rituximab biosimilar, which references Roche’s Rituxan/MabThera (rituximab). Rituximab made CHF 7.3 billion (US$7.8 billion) globally in 2017 sales. The reason(s) behind the CRL have not been disclosed.
“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter,” the company said in a press statement. “While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.”
In June 2017, Sandoz’s rituximab biosimilar was approved by the European Commission (EC) in all indications. This was the second biosimilar approval for the reference product in 2017. In February 2017, Celltrion, an Incheon, South Korea-based pharmaceutical company, also received approval from the EC for Truxima (rituximab), another biosimilar to Roche’s rituximab.
Then in April 2018, Celltrion was issued two CRLs from FDA for the BLAs for CT-P10 (rituximab), a proposed biosimilar to Roche’s rituximab, and CT-P6 (trastuzumab), a proposed biosimilar to Roche’s Herceptin (trastuzumab). Trastuzumab made approximately CHF 7.01 billion (US$7 billion) in 2017 sales.
Celltrion’s CRLs stem from a warning letterthat FDA issued to the company on Jan. 26, 2018 after an inspection carried out from May 22 to June 2, 2017 at Celltrion’s drug manufacturing facility in Incheon, South Korea. The letter raised issues related to certain manufacturing processes at the facility. During the inspection, personnel saw poor aseptic practices during the set-up and filling of batches, among other violations.
In addition to Sandoz and Celltrion, Pfizer also received a CRL in April 2018from FDA in response to the BLA for the company’s proposed trastuzumab biosimilar, which references Roche’s trastuzumab.