Supreme Court will rule on the validity of the timing.
If the Acting US Solicitor General’s recommendation is accepted, the US Supreme Court will rule on the validity of the timing of the 180-day notification rule as well as on the so-called patent dance itself.
The amicus brief was filed on December 7, in response to a lower court decision on Sandoz v. Amgen, in which the plaintiff did not take actions consistent with the patient dance in readying Zarxio for the market. The lower court ruling, which stated that Sandoz could not file the 180-day notification of its intent to market Zarxio until it received FDA approval, prevented the biosimilar manufacturer from launching until September 2015, 6 months after receiving approval. Immaterial to patent litigation, which begins years before FDA approval (and seems to extend well beyond the notification period in most US cases), this was essentially an additional 6-month period of exclusivity, which was not the intent of the Biologic Price Competition and Innovation Act. In other words, if a manufacturer wanted to launch while still embroiled in patent litigation, that drug maker should be able to do so, “at risk,” which is the position taken by Pfizer and Celltrion in launching Inflectra™. The argument was made that the 180-day notification should be permitted earlier in the process, for instance, when it applies for FDA approval, so it does not interfere with product launch.
Although Zarxio is already on the market, Sandoz has other biosimilars in various stages of approval and development that are still subject to the lower court ruling (e.g., its etanercept biosimilar has been approved, but is awaiting the 180-day period before marketing in 2017).
If the Supreme Court takes up the recommendation, it is likely to hear the case during the current term and vote on it by July 2017.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
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.