Celltrion and Daewoong are not expecting the U.S. Food and Drug Administration’s 483 Warning Letter will become an obstacle to their efforts to enter the U.S. market, company officials said.

The two companies have recently received the 483 Warning Letter from the FDA -- Celltrion on June 2 last year and Daewoong on Jan. 19 this year.

The FDA sends 483 Warning Letter to drugs, food, medical devices, cosmetics, manufacturing businesses that violate the rules of procedures and internal systems. Companies that receive the warning letter must respond within 15 business days.

After media outlets reported the news, the stock prices of the two companies declined, while the negative outlook for the companies entering the U.S. market emerged.

However, the two companies pointed out that the FDA 483 Warning Letter does not necessarily mean problems with their advances into the U.S. market.

Other pharmaceutical industry officials also noted that the FDA usually delivers the warning letter after it completes GMP inspection.

In response to such concerns, Daewoong released a statement claiming that the FDA typically issues the document after inspection and it poses no threats to the company’s winning the sales approval.

“Contrary to some people raising concerns about a serious defect, the problems mentioned in the observations can be solved,” a Daewoong official said. “Also, the FDA report does not indicate violations of GMP, but rather observations, unlike some news reports that suggested the letter pointed out violations related to the company's manufacturing processes.”

Celltrion also issued a statement saying that it has already sent a report to the FDA after correcting the problems in the warning letter in November. The company added that it submitted additional supplemental data upon request from the FDA last month.

“The company has already received confirmation of the quality of its products such as Remsima, Herzuma and Truxima from the GMP regular audits conducted by European Medicines Agency in November 2017,” a Celltrion official said. “There is no impact on domestic production or U.S. sales of Remsima, sold in the U.S. as Inflectra, following the FDA’s request for additional supplemental data.”

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