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FDA warns factory making Pfizer biosim for Aust
Posted 9 February 2018
The FDA has issued a warning letter to biosimilar manufacturer Celltrion for its South Korean facility which produces the biosimilar Inflectra for the Australian market.
Inflectra, a biosimilar of Janssen's immunotherapy Remicade, is licensed to Pfizer in Australia. It was PBS listed in December 2015.
A Pfizer spokesperson yesterday confirmed to Pharma in Focus that the South Korean factory issued with the warning letter last month was the source of Inflectra for Australia but said local supplies were not impacted.
"The Celltrion facility manufactures and supplies Inflectra for the Australian market," the spokesperson said.
"Patient safety is of primary importance to Pfizer, and the company is committed to ensuring the safety and quality of our medicines.
"Pfizer takes seriously its responsibility to ensure that all our products are produced and sourced in accordance with all applicable local and international regulatory standards.
"We stand behind the safety, efficacy and quality of Inflectra. We do not anticipate any disruption to Inflectra supply."
Dated 26 January 2018, the FDA letter to Celltrion raised issues about the company's pharmaceutical manufacturing process detected during an inspection in mid-2017.
"This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the letter states.
The FDA warning letter details numerous violations of its CGMP, including failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products and failing to thoroughly investigate unexplained discrepancies or failures of a batch or any of its components.
Celltrion responded that it was "making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues with highest priority".
Celltrion said it would respond to the FDA, addressing its concerns by mid-February.
Megan Brodie
Posted 9 February 2018
The FDA has issued a warning letter to biosimilar manufacturer Celltrion for its South Korean facility which produces the biosimilar Inflectra for the Australian market.
Inflectra, a biosimilar of Janssen's immunotherapy Remicade, is licensed to Pfizer in Australia. It was PBS listed in December 2015.
A Pfizer spokesperson yesterday confirmed to Pharma in Focus that the South Korean factory issued with the warning letter last month was the source of Inflectra for Australia but said local supplies were not impacted.
"The Celltrion facility manufactures and supplies Inflectra for the Australian market," the spokesperson said.
"Patient safety is of primary importance to Pfizer, and the company is committed to ensuring the safety and quality of our medicines.
"Pfizer takes seriously its responsibility to ensure that all our products are produced and sourced in accordance with all applicable local and international regulatory standards.
"We stand behind the safety, efficacy and quality of Inflectra. We do not anticipate any disruption to Inflectra supply."
Dated 26 January 2018, the FDA letter to Celltrion raised issues about the company's pharmaceutical manufacturing process detected during an inspection in mid-2017.
"This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the letter states.
The FDA warning letter details numerous violations of its CGMP, including failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products and failing to thoroughly investigate unexplained discrepancies or failures of a batch or any of its components.
Celltrion responded that it was "making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues with highest priority".
Celltrion said it would respond to the FDA, addressing its concerns by mid-February.
Megan Brodie
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