After defeat in Europe, Celltrion outruns Samsung Bioepis in getting US approval for Avastin biosimilar

[Celltrion Vegzelma (Celltrion present=Yonhap News)]

By Kwang-Ho Lee

Celltrion got an approval for Vegzelma in the U.S., the world’s leading pharmaceutical and biotech market, after the company received approvals in Europe and Japan for its biosimilar to Avastin.

The original bevacizumab, sold under the brand name Avastin, is a targeted agent developed by Genentech, a subsidiary of a multinational pharmaceutical firm, Roche. The medication inhibits the growth of new blood vessels, so that cancer cells are malnourished. Regardless of body parts, it targets the vulnerability found in most cancer cells, so it has been used widely to treat various cancers, such as breast cancer, non-small cell lung cancer, renal cancer and liver cancer. The size of the global market for the drug therefore reached 8.97 trillion won ($6 billion) last year, proving its huge popularity.

Throughout this year, Celltrion has accelerated its efforts to get approvals for Vegzelma, after settling a patent dispute with the Avastin developer in May. The Korean firm received Europe’s approval for Vegzelma last month and got the approvals in Japan and the U.S. this month. Its product is expected to be released in Europe in November and the U.S. during the first half of next year.

Celltrion tops among late movers in US
When comparing Celltrion with its rivals, it can be much easier to realize how fast the company was in getting the U.S. approval. Although multiple companies have already released Avastin biosimilars, they have differed in getting approvals for their products in each region.

In the U.S., there are two types of Avastin biosimilar – Mvasi released in 2019 by Amgen, which settled its dispute with Genentech in July 2020, and Jairabeve released in January 2020 by Pfizer. However, there has been no additional late movers since then. Although Samsung Bioepis applied for an approval for its product in September 2019 and Centus Biotherapeutics, a joint venture between Japan’s Fujifilm and AstraZeneca, has sought for an approval since 2020, none of them have received the green light.

Against this backdrop, Celltrion became the first late mover to get the U.S. approval, even though it had submitted its application last September, later than its competitors.

“There wasn’t any special event that enabled such an early approval,” a Celltrion official said. “It seems that the authorities took into account the fact that we have already got the U.S. approvals for three other biosimilars and that we are experienced in this field.”

In Europe, Celltrion has lagged behind its rivals. While Amgen and Pfizer, as well as Samsung Bioepis and Centus, released their products at the time Avastin went off patent in Europe in January, Celltrion failed to release its product at that time, as it had belatedly applied for an approval last October. In summary, Celltrion fell behind its chief rival, Samsung Bioepis, in Europe, but the former has been a step ahead of the latter in the U.S.

Price competitiveness key to vie with multinational drugmakers
However, it is obvious that Celltrion is a late mover in the U.S. market. According to Hana Securities, Amgen’s biosimilar occupied 46 percent of the U.S. bevacizumab market as of last month, followed by Pfizer’s with 37 percent and the original Avastin with 17 percent. This shows that Celltrion needs to engage in a fierce market competition with other biosimilar makers. The company therefore needs to secure a meaningful size of market share, before the two other late movers release their products.

“It is definite that we are a late mover,” the Celltrion official said. “We have been contemplating various measures to reduce costs and enhance cost efficiency. We have also prepared to introduce our direct sales system to the U.S., as we did in Europe.”

*This was translated from the article originally written in Korean. For more accurate information, please refer to the original version by using the link below. In case of discrepancies between the two versions, the Korean version shall prevail.

https://n.news.naver.com/article/374/0000304434

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