South Korea's Celltrion and Samsung Bioepis are poised to gain new or expanded approval for biosimilars of some of the world's best-selling biological drugs, setting up a regulatory knowledge base on approvals and bringing commercial competition to major drugmakers not unlike that seen by small-molecule generics from India decades ago.
Celltrion and Hospira's ($HSP) biosimilar versions of Merck & Co. ($MRK) and Johnson & Johnson ($JNJ) developed Remicade, Remsima and Inflectra, respectively, are now sold in more than 40 countries.
Hospira released data this week showing patients treated with Remicade for four years experienced no change in patient symptoms, disease activity or safety signals when they were switched to the biosimilar version.
And Samsung Bioepis has submitted a marketing authorization application to the European Medicines Agency or SB2, also a biosimilar of Remicade.
However, U.S. approval awaits and earlier statements that 2015 may be on the cards seem slim as the U.S. FDA has not scheduled an advisory committee meeting since cancelling a planned one in February.
A report, however, said that Liz Pollitt, a vice president of Regulatory Affairs at Celltrion, told a conference the regulator has asked for more details of the statistical date used in the application.
"We have had a lot of communication with the stats unit of the FDA, and we actually first asked them the question to which they eventually got back to us," she said, according to BioPharma-Reporter. "In some case they are asking us to unpool our data and in other cases they want us to pool it so we're not quite certain what they are looking for there." She added, the publication said, that they "still haven't seen any sign of an FDA guideline on statistical analysis."
She said Celltrion continues to work closely with the FDA and is also discussing interchangeability as the company is not quite certain what the requirements will be in the U.S. FiercePharmaAsia could not immediately reach Pollitt.
But the larger stakes are clear for both companies in the biosimilar market in the United States and globally, the Financial Times reports, noting a forecast by Citigroup.
The ability to manufacture, clinically test and then get regulatory approval, however, is where South Korean companies will possibly stand out, the Financial Times notes. Other South Korean companies are also in it for the long game, the Financial Times said, "aiming to capture a big share of the $110 billion of value that Citigroup expects to flow from innovator companies to biosimilars over the next decade."
This is a similar process to Indian companies such as Sun Pharmaceutical Industries using the patent expiry route in the United States to gain a toehold in the world's top market.
This has also placed the companies and the country at the center of a supplier and services market in Asia for clinical trials, high-end manufacturing and other equipment and talent.
Olivier Loeillot, Asian general manager of GE Healthcare's ($GE) bioprocessing business, told the Financial Times that Celltrion and Samsung Bioepis have moved "very quickly" to become serious players.
Still, they are not charging, or making as much, as the originators, with discounts reported as high as 70% for Remicade in Europe.
But Kim Hyung-ki, Celltrion's CEO, told the Financial Times that pricing power will increase alongside evidence showing its product is safe.
"As we provide that kind of long-term data, more doctors will prescribe the product," he told the Financial Times.
Merck & Co. and Samsung Bioepis this week said SB4, a biosimilar of Amgen's ($AMGN) Enbrel (etanercept), and SB2, the Remicade biosimilar, met primary endpoints of Phase III studies in patients with moderate to severe rheumatoid arthritis.
Earlier, Samsung Bioepis said it could launch Enbrel in South Korea late this year and in Europe in early 2016.
The company is also said to be in the final stage of a Phase III global clinical trial of SB9, a biosimilar of Sanofi's ($SNY) Lantus (insulin glargine).
Samsung Bioepis is a joint venture between Samsung Biologics and Biogen ($BIIB).
- here's the release
- and a story from the Financial Times (sub. req.)