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FDA Issues Warning to Coherus Partner Over Cancer Drug

The U.S. Food and Drug Administration (FDA) has flagged issues at a China manufacturing plant that supplies Coherus BioSciences Inc with a cancer drug, the company said on Wednesday.

The FDA issued a Form 483, a type of warning letter, to the plant in Changzhou, China, which is owned by Coherus' partner, Shanghai Henlius Biotech Co Ltd. The FDA found that the plant did not have adequate controls in place to prevent contamination of the drug, adalimumab, which is used to treat rheumatoid arthritis and other autoimmune diseases.

Coherus said it is working with Henlius to address the FDA's concerns and expects to resume shipments of adalimumab from the plant in the coming weeks. The company said it has enough adalimumab on hand to meet patient demand during the disruption.

The FDA's action is a setback for Coherus, which is seeking to expand its manufacturing capabilities in China. The company has been working to build a plant in Suzhou, China, but that project has been delayed.

Coherus is not the only drugmaker that has had problems with its manufacturing plants in China. In recent years, the FDA has issued Form 483s to a number of other drugmakers, including Novartis AG, Pfizer Inc and Johnson & Johnson.

The FDA's increased scrutiny of Chinese drugmakers is part of a broader effort to improve the safety of imported drugs. The agency has been concerned about the quality control standards at some Chinese manufacturing plants.

In 2015, the FDA issued a warning letter to a Chinese manufacturer of heparin, a blood thinner, after it found that the company had falsified data and failed to follow good manufacturing practices. The warning led to a nationwide shortage of heparin.

The FDA's action against Coherus is a reminder of the risks associated with importing drugs from China. Patients should talk to their doctors about the potential risks and benefits of taking any drug, regardless of where it is made.

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