Coherus BioSciences, Inc (NASDAQ: CHRS) had been waiting anxiously to get a chance for launching their bio-similar of Neulasta, Amgen (NASDAQ: AMGN)- the drug that is used to stimulate white blood cell production after cancer treatment and brought in more than $4.6B last year for Thousand Oaks, California based Amgen. But before Coherus could get any approvals, Amgen is dragging Coherus into a court battle, filling a trade secret action, alleging trade secret misappropriation & other claims against Coherus. According to Amgen, 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 CEO Denny Lanfear “categorically” rejected the allegation & stated that action is without merit, while suggesting that Amgen’s lawsuit represents baseless litigation to delay Coherus from entering the pegfilgrastim market as a serious competitor.
Coherus’ Neulasta biosimilar, now known as CHS-1701, is scheduled for FDA decision on 9th of June. Meanwhile, in the lawsuit, Amgen seeks several injections against Coherus, plus restitution and damages. One of the Barclays analysts wrote that this suit could have negative impact on Coherus as its regulatory approval date gets closer.
Dan Lanfear also added that Coherus is keen on introducing competition & offering biosimilar products at competitive prices with and lower than those sustained by Amgen and other large pharma companies. And according to the data, bio-similar have reached the U.S market with 15% discount to the brands from large Pharmaceutical companies.
Amgen is also locked in a court battle over Sandoz’ biosimilar version of its Neulasta predecessor, Neupogen, with case scheduled for arguments before the U.S Supreme court next month, and it is certain that high court’s decision is expected to influence future bio-similar patent fights & launch dates.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
Information on Bio-similar Products:
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Please visit for more: www.fda.gov/Drugs
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