- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Breaking: US Supreme Court to Hear Biosimilars Lawsuits
Which road will the courts take?
Breaking News - as reported by Seeking Alpha:
In what many observers and market players hope will clarify the biosimilar approval route, the U.S. Supreme Court has agreed to hear two related lawsuits over certain Obamacare provisions governing biosimilars.
The dispute centers on Novartis (NVS -0.5%) Sandoz unit's marketing application for its biosimilar to Amgen's (AMGN +0.5%) Neupogen (filgrastim), approved in the U.S. in September 2015. Sandoz is marketing the product under the brand name Zarxio.
Amgen sued Sandoz in an attempt to block Zarxio's approval but failed. The ruling by the U.S. Court of Appeals, which set the approval date, was a bit muddled. Amgen and Sandoz both filed suit against portions of the decision.
The Appeals Court said Sandoz was not required to give Amgen information about its biosimilar application, including a description of the manufacturing process. It added that Amgen could file a patent infringement suit instead (it did so, the trial is set to start in December).
Amgen's position is that the law says Sandoz "shall" give the information and the failure to do so warrants an injunction barring Zarxio sales. Sandoz sued over the requirement that it had to give Amgen 180 days' notice after FDA approval before it could start selling the product.
The specific date of the hearing has not been set.
Source: SeekingAlpha.com
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Breaking Down Biosimilar Barriers: Payer and PBM Policies
November 13th 2024Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
