HONG KONG – Japanese pharma major Daiichi Sankyo Co. Ltd., looking to enter the biosimilar game, reported positive results from a co-developed drug that could become the country's first biosimilar etanercept.

Daiichi (TSE:4568), along with U.S. partner Coherus Biosciences Inc., said their biosimilar version of Amgen Inc.'s Enbrel has achieved the major objectives of its joint phase III trial for rheumatoid arthritis (RA) in Japan. Daiichi expects the drug to be the company's debut product in the biosimilar space.

"The trial being conducted by Daiichi Sankyo is only for the purpose of obtaining the rheumatoid arthritis indication," Daiichi's manager of media relations, William Henning Jr., told BioWorld Today. "Coherus is also conducting a trial with CHS-0214 for chronic plaque psoriasis, although Daiichi is not involved.

"At the current time, the only [Daiichi] biosimilar for the Japan market in the clinical trial phase is CHS-0214," Henning added. "However, we are evaluating both proprietary as well as collaborative options for other biosimilars."

The phase III trial of CHS-0214 is a randomized, double-blind, active-control, parallel-group study conducted globally to compare the safety and efficacy of the candidate with Enbrel. The trial, launched in August 2014, recruited RA patients with inadequate response to methotrexate. The primary endpoint is 20 percent improvement according to American College of Rheumatology criteria at 24 weeks.

In addition to meeting equivalence requirements, data showed that patients administered CHS-0214 had no significant difference in the reported adverse events with the reference groups. CHS0214 is now undergoing the open-label extension study, which is currently recruiting participants. The extension study will evaluate the longer-term safety and durability of the drug over another 24 weeks – for 48 weeks total – and is estimated to be complete in 2017.

"We are aiming for a launch in fiscal year 2017," said Henning.

Daiichi and Coherus established their collaboration in May 2012 for the development of Coherus' biosimilar versions of etanercept and rituximab. The two companies agreed to co-develop, manufacture and commercialize the two biosimilars. Daiichi is responsible for marketing the products in Japan, South Korea and Taiwan; the rest-of-the-world rights were retained by Coherus. Financial terms were not disclosed. (See BioWorld Today, May 8, 2012.)

"Coherus Biosciences has established an outstanding business model, a very experienced biologic development team and outstanding capabilities," Daiichi President and CEO Joji Nakayama said when the deal was announced. "By creating an opportunity for an early entry into the biosimilars market, this agreement will strengthen our internal platform for manufacturing and developing biopharmaceuticals, leading directly to the introduction of other biosimilars therapies in the future." Coherus has another partner for the development and marketing of CHS-0214 in other countries: U.S. health care company Baxter International Inc.'s biopharma spin-off Baxalta Inc.

Baxter started out with a $216 million collaboration with Coherus for biosimilar etanercept in 2013 for the drug's commercialization in Europe, Canada, Brazil and certain other markets. Baxter then added $12 million more to expand the partnership and agreed to buy Coherus' shares. After the Baxter-Baxalta split, the biopharma business including the deal passed to Baxalta. (See BioWorld Today, Sept. 4, 2013.)

Baxalta, which is in the process of being acquired by Shire plc, and Coherus updated progress of CHS-0214's phase III trials in Europe last week. The drug is a biosimilar version of Amgen's bestselling Enbrel, which earned $1.4 billion in the third quarter of 2015.

Japan's pharmaceutical regulatory body, the Pharmaceutical and Medical Device Agency, has approved seven biosimilar drugs so far, including biosimilar infliximab, insulin glargine, somatropin, filgrastim and epoetin alfa. The first was Sandoz Inc.'s biosimilar somatropin, approved in 2009.

The only biosimilar drug approved that also targets RA is South Korean biosimilar maker Celltrion Inc.'s Remsima. Celltrion co-conducted the clinical trial in Japan with partner Nippon Kayaku Co. Ltd. The drug is the biosimilar version of Janssen Biotech Inc.'s Remicade.

To date, Remsima has racked up 62 approvals and aims to get many more. It was approved in Japan on July 4, 2014, for the indications of Crohn's disease, ulcerative colitis and RA. (See BioWorld Today, Aug. 28, 2015).

Indian pharma company Torrent Pharmaceuticals Ltd. also has made progress by launching its biosimilar adalimumab with the brand name Adfrar. The drug treats autoimmune diseases such as RA, ankylosing spondylitis, psoriatic arthritis other indications. The originator drug, Humira (Abbvie Inc.), is one of the biggest sellers in the world.