A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.
A panel of judges for the United States Court of Appeal for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.
Last month, Amgen launched the first anticancer biosimilars, Kanjinti (trastuzumab) and Mvasi (bevacizumab) in the United States. The pair of launches came after the United States District Court for the District of Delaware denied a motion from rival drug maker Genentech to block the launch of Kanjinti.
The trastuzumab biosimilar references Roche and Genentech’s Herceptin, and Genentech had asked the court to block Amgen from launching the product. According to the court’s decision in the case, Genentech failed to show that it would suffer irreparable harm if its motion were denied.
It went on to say that, given that Genentech was aware since May 2018 that Amgen planned to launch its biosimilar, and given that Genentech received other information from Amgen in the discovery process that alerted it to the Kanjinti launch date, Genentech’s late request—filed in July 2019—for a restraining order was “contrary to the spirit and purpose of the BPCIA,” which gives parties ample time to adjudicate disputes without seeking immediate intervention by the court.
Next, Genentech filed an appeal. Now, in a 1-page order filed this week, the court denied Genentech’s motion for an injunction that would have barred sales of Kanjinti pending the resolution of the appeal.
According to the panel, “we conclude that Genentech has not established that an injunction pending appeal is warranted here,” though the determination is without prejudice to the ultimate disposition of the case. The panel also said, in response to Genentech’s request to expedite the appeal, that Genentech has not demonstrated that Amgen is able to expedite its filings in the case.
With respect to a separate action related to bevacizumab, which revolved around 2 patents owned by Genentech related to manufacturing processes for bevacizumab, the United States District Court of the District of Delaware also recently denied an emergency motion for a temporary restraining order and a prohibition on commercial marketing of Amgen’s Mvasi, which references Genentech’s Avastin.
Genentech had argued that because the FDA approved supplements to Amgen’s Biologics License Application (BLA) for the biosimilar, Amgen should provide new notices of marketing related to those supplements.
The court disagreed, saying that the Mvasi product that was subject to the FDA’s original approval is the same as the product for which supplements to the BLA were also approved. The court found that Genentech could not succeed on the merits, and “that finding alone necessitates denial of Genentech’s motion.”
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
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.
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.