April 20, 2024

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[THE INVESTOR] South Korea's biosimilar developer Celltrion on March 31 said it has filed two petitions to nullify Genentech’s patents for the breast cancer treatment Herceptin in the US before its planned entry into the market with its own copycat version Herzuma.

The Korean drug maker said the petitions aim to cancel patents related to methods of administration and dosage for the blockbuster drug that expire in 2030. 

Park Hyun-koo/The Investor

“This is a legal step for Herzuma to be recognized as being as effective as the original drug in the upcoming regulatory review by the US authorities,” a Celltrion official said. “We plan to file for the US Food and Drug Administration’s approval within the first half of this year.”

Celltrion has recently started a patent war against the California-based Genentech whose Herceptin sales reach an annual US$7 billion. The company has filed a total of five petitions, including the latest two, over the past two months.

In the meantime, Herzuma has received sales approval in Europe and South Korea thus far.

By Park Han-na (hnpark@heraldcorp.com)