A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed.
A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed. Big Molecule Watch reports that Magistrate Judge Christopher J. Burke made a sealed recommendation that Coherus be granted its motion to dismiss the entire suit, and Coherus expects the District Court to decide in the first quarter of 2018 whether to adopt the recommendation.
Amgen’s original complaint, arising from the Biologics Price Competition and Innovation Act (BPCIA), asserted that Coherus would infringe on 1 or more claims of its US Patent Number 8,273,707 (the so-called ‘707 patent), which relates to a process for purifying a protein by mixing a protein preparation with a solution, if the FDA approved Coherus’ pegfilgratim biosimilar, CHS-1701. Amgen, the maker of the reference pegfilgrastim, Neulasta, claimed that “Coherus is piggybacking on the fruits of Amgen’s trailblazing efforts” in developing the biosimilar product.
In June 2017, Coherus filed its motion to dismiss the BPCIA litigation, saying that Amgen had failed to state a claim on which relief could be granted by the court. After Coherus received a complete response letter from the FDA for CHS-1701 just weeks after filing its motion (and subsequently terminated approximately 30% of its workforce in an attempt to streamline operations and save costs), the company in July moved for a stay of discovery in the case pending the motion to dismiss. The biosimilar developer cited the need to preserve its financial resources in light of the regulatory setback. Amgen, according to Coherus, could “use its vast resources to bankrupt Coherus with unnecessary litigations expenses before Coherus can launch [CHS-1701].”
Coherus has also been defending itself against Amgen in a California state court; in March, the reference pegfilgrastim maker filed a complaint that Coherus had engaged in a “massive conspiracy” to steal trade secrets concerning pegfilgrastim. The lawsuit alleged that Coherus induced Amgen employees to breach confidentiality agreements and to transmit proprietary knowledge to Coherus on stolen USB drives. Coherus rejected the allegations as baseless.
Coherus reports that its development of CHS-1701 is on track for resubmission of its Biologics License Application to the FDA by early 2018. Meanwhile, the biosimilar developer continues phase 3 clinical development of adalimumab (Humira) and etanercept (Enbrel) for the US market, and has begun preclinical activities related to its ranibizumab (Lucentis) biosimilar.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.