- Coherus BioSciences has lost another pharma backer for development of its biosimilar version of Amgen's Enbrel (etanercept), putting new pressure on the biosimilar manufacturer after an regulatory rejection in the U.S. prompted staff cuts last week.
- Japanese drugmaker Daiichi Sankyo said Wednesday it would discontinue development of Coherus' Enbrel copy in its home country of Japan, citing issues with manufacturing and supply of the biosimilar.
- Last fall, Shire ended its agreement with Coherus to develop the same Enbrel biosimilar for Europe, Canada and other territories, handing back development and commercial rights to Coherus.
The Food and Drug Adminsitration's rejection of Coherus' copy of Amgen's neutropenia drug Neulasta (pegfilgrastim) last month has dented the fortunes of the biosimilar-focused drug developer.
News of the complete response letter (CRL) sliced nearly 24% off the value of shares in Coherus and led to layoffs for roughly 30% of the company's workforce.
Coherus previously hoped to secure a U.S. approval for its Neulasta biosimilar last quarter and had been preparing a commercial launch of the copycat biologic.
While the drugmaker said it will meet with the regulator to determine next steps, the rejection is a missed opportunity to stake out a lead targeting the blockbuster biologic.
Daiichi's decision to back out of further development of the Enbrel biosimilar leaves Coherus without a pharma partner for ex-U.S. territories. Coherus retained development and commercialization rights in the U.S. while inking license agreements with Baxalta (now Shire) and Daiichi for European and Japanese development.
The Japanese drugmaker said its decision was due to the inability to establish a commercial manufacturing process capable of ensuring supply of CHS-0214 — as the Enbrel biosimilar is known — in Japan.
Under the original 2012 deal for rights to the biosimilar, Coherus agreed to be responsible for manufacturing and supply of the product during development. The agreement also granted Daiichi an option to obtain a license to manufacture the biosimilar itself, exercisable within an unspecified time period.
"We are currently reviewing our development program for CHS-0214 in light of our recent CHS-1701 CRL from the FDA and this decision by Daiichi. No final decisions have been made at this time," the company said in a statement on Daiichi's announcement, referring to the Neulasta biosimilar by its development name.
Coherus had planned to file a Marketing Authorization Application with the European Medicines Agency for the biosimilar in the second half of this year. The drugmaker said in a recent securities filing it will look for commercialization partner for CHS-0214 in Europe and other ex-U.S. jurisdictions.
In the U.S., Coherus doesn't expect to commercialize the biosimilar prior to expiration of several patents held by Amgen on Enbrel that don't lapse until 2028 and 2029 — unless successfully challenged.
Coherus is also developing a biosimilar version of AbbVie's Humira (adalimumab) and recently won a favorable ruling that invalidated one of many patents protecting the drug from competition.
Editor's note: Coherus BioSciences responded to BioPharma Dive's request for comment after publication and this article was updated to include the company's statement.