Amgen Settles With One Biosimilar Developer, Sues Another

Kelly Davio

Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.

Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. The case revolved around trade secrets related to Amgen’s innovator pegfilgrastim, Neulasta.

In a lawsuit filed in 2017, Amgen claimed that Coherus had engineered a conspiracy to steal its trade secrets relevant to Neulasta when it was seeking to develop its pegfilgrastim biosimilar, Udenyca; the alleged conspiracy included recruiting Amgen’s employees to work for Coherus, said Amgen, and the receipt of sensitive information related to, among other aspects of its business, Amgen’s operating procedures, analytical methods, contracting strategies.

Coherus denied the accusations at the time, and suggested that the lawsuit was, as Chief Executive Officer Denny Lanfear said in a 2017 statement, “best understood as an effort by Amgen to use baseless litigation in an effort to delay Coherus as a competitor in the pegfilgrastim market.”

In its May 2 announcement, Coherus said that, while the details of the settlement reached in the case are confidential, Coherus will continue to market its FDA-approved Udencya and will pay a “mid-single digit royalty” to Amgen for the next 5 years.

“This settlement allows us to put this matter behind us and fully focus on the robust launch we have underway,” said Lanfear in a statement.

Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis. This action relates to the newly approved etanercept biosimilar, Eticovo, which references Amgen’s innovator etanercept, Enbrel.

The complaint, filed by Amgen, Hoffman-La Roche, and Immunex in the District Court of New Jersey, alleges infringement of 5 patents under the Biologics Price Competition and Innovation Act (BPCIA).

The complaint also states that Samsung Bioepis did not comply with the requirements of the BPCIA by failing to provide relevant information, such as a copy of its application for the drug and 180-day commercial marketing notification, for the drug.

Amgen, Hoffman-La Roche, and Immunex have asked the court to enter a judgment in their favor, to issue a restraining order to keep Samsung Bioepis from making or selling the biosimilar, and a preliminary injunction restricting making or selling the biosimilar until 180 days after Samsung Bioepis provides its notice of commercial marketing and until the suit has concluded. The complainants have also demanded a jury trial in the case.