Anxiously awaiting its chance to launch a biosimilar of Amgen’s blockbuster Neulasta, Coherus Biosciences faces allegations of a "massive conspiracy" to swipe its rival's trade secrets. The alleged violations, per Amgen's lawsuit? Coherus poached Amgen employees to get at their proprietary knowledge.
In its new lawsuit, Amgen claims Coherus engineered a "massive conspiracy" to steal its information, according to analysts at Barclays. That conspiracy, Amgen says, included recruiting its employees, who then siphoned off secrets and passed them to Coherus.
Coherus allegedly received information on “stolen” USB drives, including “sensitive Amgen standard operating procedures, laboratory notebook pages, validated analytical methods, method development reports, specifications, documents reflecting process optimization work, cost calculators and pricing and contracting strategies,” the analysts say.
But Coherus “categorically” rejects the allegations, CEO Denny Lanfear said in a statement, and accused Amgen of using the lawsuit to stave off competition.
Amgen's lawsuit is “best understood as an effort by Amgen to use baseless litigation in an effort to delay Coherus as a competitor in the pegfilgrastim market,” Lanfear said.
Coherus' Neulasta biosim, now known as CHS-1701, is scheduled for a June 9 decision date at the FDA. In its lawsuit, Amgen seeks several injunctions against Coherus, plus restitution and damages. Barclays’ analysts wrote the suit is “undoubtedly a negative” for Coherus as its regulatory date nears.
Still, the Barclays analysts figure “the more overt emphasis on commercial trade secrets may in fact offer support to [Coherus’] view that Amgen’s action is a stalling practice to keep” the Neulasta biosim from reaching the market.
Used to stimulate white blood cell production after cancer treatment, Neulasta brought in more than $4.6 billion last year for Thousand Oaks, California-based Amgen.
Coherus is intent on “introducing competition and offering biosimilar products at prices competitive with and lower than those maintained by Amgen and other large pharmaceutical companies,” Lanfear said in his company's statement. So far, biosims have reached the U.S. market with discounts of about 15% to the brands.
Amgen represents a key player in the budding U.S. biosim market. The company last year won an FDA approval for its version of AbbVie’s best-selling Humira, but that launch is tied up by legal fighting. Amgen is also locked in a court battle over Sandoz' biosimilar version of its Neulasta predecessor, Neupogen. That case scheduled for arguments before the U.S. Supreme Court next month, and the high court's decision is expected to affect future biosimilar patent fights and launch dates.
Earlier this year, the company caught some good news when challenger Sandoz indicated it wouldn’t launch a biosim of anti-TNF blockbuster Enbrel before 2018 due to another legal fight.