SEOUL – South Korea’s biosimilar frontrunner Celltrion Inc. received approval from the Ministry of Food and Drug Safety for sales in Korea of Herzuma (trastuzumab), a biosimilar of Roche’s blockbuster Herceptin (trastuzumab). MFDS approved the compound for early and advanced HER2-positive breast cancer and for advanced stomach cancer.

The product is Celltrion’s second approved monoclonal antibody biosimilar following Remsima, a biosimilar of Johnson & Johnson’s tumor necrosis factor inhibitor Remicade (infliximab). Remsima is available in Korea and in August 2013 received marketing approval from the European Commission ([A#28131011005]).

Celltrion filed for Korean regulatory approval of Herzuma in June 2013 based on global clinical trials of 558 patients in 18 countries and 115 sites ([A#28130605007]).

The company noted its product is the first biosimilar of trastuzumab to receive approval based on global clinical trial results. Biocon Ltd. received the first approval for a trastuzumab biosimilar after clearing the Drug Controller General of India based on domestic Phase III trials. Biocon has ongoing Phase III trials for its trastuzumab biosimilar in Europe ([A#28131122006]). Mylan NV is Biocon’s global partner for developing biosimilars ([A#28130213015]).

“Celltrion will be launching the product in the Korean market in two or three months after some regulatory processes by the Ministry of Health and Welfare and MFDS,” the company told PharmAsia News, noting that Herzuma will be sold at a price at least 30% cheaper than Herceptin in South Korea, in addition to a mandatory price cut for Herceptin.

When generics are launched in Korea, the original product price is automatically reduced by 30%. According to Korean law, generic drugs are priced initially at 59.5%-70% of the original drug price and are lowered again to 53.55% of the original price after the first year the generic is on the market. Korean regulators set Remsima’s price at KRW 370,892 ($327.61), or 66.5% of Remicade’s price of KRW 557,732 ($492.65) ([A#28130530008]).

Celltrion said it would file for approval of Herzuma in the U.S. and Europe soon, although it did not disclose any timeline for the filings. The company estimates Herceptin generates approximately KRW 80 billion ($80 million) in sales in South Korea.

Herceptin generated CHF 5.889 billion ($6.486 billion) in sales for Roche in FY 2012, making it the pharma’s second-largest product for the year.

Keeping The Competition At Bay

Roche has exerted significant R&D effort to fight off competition from Herceptin biosimilars by turning to development of successor products like Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine) to differentiate safety/efficacy profiles Also see "Beyond Herceptin, Roche Readies Breast Cancer Successors, Braces For Biosimilars" - Pink Sheet, 11 June, 2012..

In addition to Biocon’s India launch, Pfizer Inc., Amgen Inc. and Hospira Inc. are all pursuing development of Herceptin biosimilars. Amgen disclosed it initiated a pivotal trial for a Herceptin biosimilar in 2013, as did Pfizer for its Herceptin biosimilar in July 2013. Hospira is partnered with Celltrion in Europe for Herceptin as well as Remicade biosimilars.

Roche Chief Financial Officer Alan Hippe, speaking during a Roche breakout session at the JPM Morgan Healthcare Conference Jan. 13, said Roche believes it is “pretty protected” from Herceptin biosimilars, adding, “I don’t see a lot of threat there.”

Hippe noted that while Herceptin loses patent protection in Europe in 2015 and in the U.S. in 2018, the current clinical data available for Celltrion’s product suggests “it’s not looking like there will be a meaningful biosimilar coming to the market in 2015.”

Roche also believes it has successfully moved the standard of care to a combination therapy of Herceptin and Perjeta instead of monotherapy Herceptin. And for monotherapy Herceptin, Hippe believes Roche’s new subcutaneous formulation of Herceptin will be much more preferable to patients. Subcutaneous Herceptin requires five minutes for administration, compared to two hours for an infusion.

While Herceptin growth has slowed in developed markets, Roche reported Herceptin’s China sales grew 37% year-on-year in the third quarter.

One More In The Queue

Celltrion is also now gearing up for Phase III trials of its third biosimilar, a version of Roche’s rheumatoid arthritis drug Rituxan/MabThera (rituximab) ([A#28131031007]).

The Jan. 15 approval of Herzuma comes at a time when Celltrion is surrounded by media speculation that AstraZeneca PLC, Roche and Teva Pharmaceutical Industries Ltd. are among multinational companies showing an interest in buying the biotech. Celltrion dismissed the reports as market rumors ([A#28140110008]).

CEO Seo Jung-jin announced his intentions to sell his controlling stake in Celltrion in April 2013, but by October, South Korea’s Financial Services Commission asked state prosecutors to look into Seo for alleged price manipulation of Celltrion stock ([A#28131008006]).

The CEO has not been summoned by prosecutors since FSC filed the complaints against Seo, according to Celltrion.

[Editor’s note: This story was contributed by PharmAsia News , which provides daily coverage of the Asia biopharmaceutical industry and regulatory policies. To learn more, sign up for a free trial – no credit card needed.]

Celltrion Wins Korea Approval For Roche Herceptin Biosimilar

More from Europe

More from Geography