Back To Top
Business

Celltrion to seek US approval for Truxima, Herzuma

South Korean biopharma company Celltrion, whose biosimilar copy of Johnson & Johnson’s Remicade hit the US market last year, is planning to seek regulatory approval for two additional biosimilars in the country by next month.

Celltrion said Tuesday that it plans to file Truxima and Herzuma -- referencing Roche’s lymphatic cancer drug Rituxan (rituximab) and breast cancer therapy Herceptin (trastuzumab), respectively -- to the US Food and Drug Administration by June.
Celltrion’s headquarters in Songdo, Incheon (Park Hyun-koo/The Korea Herald)
Celltrion’s headquarters in Songdo, Incheon (Park Hyun-koo/The Korea Herald)

The company is on track to complete the filings by the first half of this year as previously stated, a Celltrion spokesperson told The Korea Herald. The firm did not share an exact timetable for the submissions.

Once approved, Truxima and Herzuma are slated to be sold in the US via Celltrion’s US marketing and sales partner Teva Pharmaceutical Industries, the world’s largest maker of generic drugs.

In the US, Celltrion’s Remicade (infliximab)-referencing biosimilar, Remsima, is already being sold via its partner Pfizer at a 15 percent cheaper price than J&J’s original drug. Biosimilars refer to cheaper near replicas of biologic drugs whose patents have expired.

Meanwhile, Remsima, has been sold in Europe from 2014 as the first-ever Remicade biosimilar introduced to the region. Truxima was approved by the European Medicines Agency in February this year and began sales in the UK in April.

The Korean drugmaker is currently awaiting the EMA’s approval of Herzuma, with expectations the agency will issue the approval by the end of this year as it made its filing in October last year.

The European sales of Celltrion’s three biosimilar drugs are being handled by multiple marketing partners including Mundipharma, Biogaran and Kern Pharma, Celltrion said.

“With our first-mover product portfolio led by Remsima, Truxima and Herzuma, and the further development of our up-and-coming new drugs, we will draw closer to our vision to step up as one of the world’s top 10 biopharma companies in the future,” the firm said in a former statement.

“We plan to quickly drive up our market share in each country to fend off rivals, while continuing to raise our reputation in the medical community by accumulating robust prescription data (that proves the safety and efficacy of our products),” it said.

Led by expanded sales, Celltrion aims to raise 860.4 billion won ($753 million) in revenue and 488.6 billion won in operating profit in 2017, according to its earnings forecast earlier this year. The company reaped 670.6 billion won in revenue and 249.7 billion won in operating profit on a consolidated basis in 2016.

By Sohn Ji-young (jys@heraldcorp.com)
MOST POPULAR