Celltrion Warning Puts Biosimilars Under Microscope

Celltrion Inc. is reeling from last month’s warning the FDA issued to the Incheon, South Korea-based biopharma company over manufacturing problems at one of its facilities there.

It’s the site where Celltrion makes Inflectra, a biosimilar to Johnson & Johnson’s Remicade product to treat rheumatoid arthritis, Crohn’s disease, psoriasis, and other conditions.

Celltrion and Pfizer Inc., which markets Inflectra in the U.S., said supplies wouldn’t be affected. But beleaguered Teva Pharmaceutical Industries Inc. said the warning might affect how quickly the FDA approves biosimilars to Genentech Inc.’s Rituxan and Herceptin.

Teva and Celltrion, which makes the active pharmaceutical ingredients for Teva’s biosimilars at the same plant, announced last year the FDA had accepted biologics license applications for them.

Apart from the impact on the companies, the FDA warning highlights the need for uniform safety and inspection standards, Alliance for Safe Biologic Medicines Executive Director Michael Reilly told me.

“[T]he Celltrion warning letter is a clarion call for the need for strong global approval standards for biosimilars,” he said.

His organization thinks there shouldn’t be an “easy point of entry” for biosimilars, he said—any biosimilar approved anywhere should come with the same guarantee of safety and efficacy.

“The letter shows that the FDA is paying close attention to the quality and safety of medicines but it does raise issues about the manufacturing processes outside of the U.S. and reinforces the need for a strong pharmacovigilance system,” Reilly said.

Biologic products require special scrutiny, as they’re more complex to make and more sensitive to light changes during manufacturing, among other features, he noted.

Reilly has confidence in the new leadership at the Department of Health and Human Services and the Food and Drug Administration to ensure “rigorous inspections and increased pharmacovigilance” for products coming in to the U.S., “but it is the weaker regulatory authorities that cause me the most concern,” he said.

“The FDA’s resources are not unlimited and their ability to conduct inspections outside the U.S. to discover problems like those at Celltrion is therefore also constrained.”

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