Amgen, a U.S. pharmaceutical company with an original drug, is filing a patent lawsuit that has blocked the osteoporosis treatment drugs Prolia and Xgeva biosimilars (biopharmaceutical generic drugs) market, which will open this year.
According to the industry on the 31st, Amgen reached an agreement with Celltrion over the weekend, bringing an end to the patent lawsuit related to Prolia and Xgeva against Celltrion. A Celltrion official noted, “With the early resolution of the patent lawsuit, we are able to proceed smoothly and stably with the U.S. launch.” However, the specific terms of the agreement were not disclosed.
This is the second agreement following the one Amgen made with the Swiss biotech company Sandoz in May of last year.
Previously, Amgen filed patent infringement lawsuits against biosimilar companies including the Swiss Sandoz, South Korea's Celltrion, South Korea's Samsung Bioepis, and Germany's Fresenius Kabi.
From the perspective of major pharmaceutical companies (Big Pharma) that hold original drugs, the introduction of biosimilars into the market poses a threat as it leads to a decrease in market share and revenue for those products. In response, global Big Pharma companies are diversifying their patents or filing lawsuits against corporations ahead of patent expiration to extend their monopolistic period.
The U.S. patent for Prolia (active ingredient denosumab) is set to expire in February of this year. Initially developed as a treatment for osteoporosis, it received approval from the U.S. Food and Drug Administration (FDA) in 2010. Subsequently, the active ingredient denosumab was proven effective in preventing bone metastasis complications in cancer patients and was approved under the name 'Xgeva' for that indication in 2013. Prolia and Xgeva are expected to generate annual sales of $6.16 billion (approximately 8.9 trillion won) in 2023, making them blockbuster drugs.
With the expiration of the original drug's patent approaching, more than 10 corporations have entered the development of Prolia and Xgeva biosimilars.
Among them, two types developed by Sandoz, Juboniti and Wios, received the first marketing authorization from the U.S. FDA last year. Earlier, the market expected that Sandoz would launch Juboniti after May of this year.
The two types developed by Celltrion, Stovoclo and Osenbelt, applied for authorization from the U.S. FDA in November of last year and are awaiting approval. The company stated that the launch date in the U.S. market is undecided. There are observations in the securities market that the Prolia biosimilar may be launched as early as June.
Samsung Bioepis has not yet reached an agreement with Amgen. The company said, “Currently, legal disputes are ongoing,” and could not comment on whether discussions for an agreement with Amgen were taking place.
Samsung Bioepis is aiming to launch the biosimilars of Prolia and Xgeva, Obodence·Xbrik in Europe within this year. In November of last year, they received a positive opinion for marketing authorization of the Prolia biosimilar from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and are awaiting final approval this year.