Celltrion said that it has completed the preliminary work for launching CT-P16, an Avastin (Ingredient: bevacizumab) biosimilar, after signing a global patent agreement for the biosimilar product with Genentech, the original developer of Avastin.

Celltrion has signed a global patent agreement with original developer Genentech for the Avastin biosimilar, CT-P16.
Celltrion has signed a global patent agreement with original developer Genentech for the Avastin biosimilar, CT-P16.

Celltrion has conducted global patent agreements with Genentech to enable early sales of CT-P16 as soon as it receives global approval.

Under the accord, Celltrion will be able to release the product stably without patent disputes. Therefore, Celltrion, unlike some of its competitors, plans to launch its products in major global markets from September for major indications, including metastatic colorectal cancer, non-small cell lung cancer, and ovarian cancer.

In Korea, however, a patent invalidation trial between other companies and original drug developers is underway, so the company will have to wait to see the ruling of the trial before launching the drug.

Celltrion has applied for approving CT-P16 to the Korean Ministry of Food and Drug Safety, U.S. Food and Drug Administration, and European Medicines Agency and is expecting to win nods this year.

If everything goes as planned, CT-P16 will mark the third anticancer antibody biosimilar in Celltrion’s product line, following the blood cancer treatment Truxima and breast cancer treatment Herzuma.

“Celltrion has concluded a global patent agreement with the original drug developer, completing pre-work for the stable market launch of CT-P16,” a company official said. “We will go all out to finalize the approval process and introduce the CT-P16 to the market as soon as possible.”

According to IQVIA, a global pharmaceutical market research institute, the worldwide bevacizumab market was estimated at $6.49 billion in 2020.

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