Courts will be busy with biosimilar litigation for the foreseeable future, attorneys predicted at a panel on the second day of the ACI 10th Summit on Biosimilars.
There have been changes to the biosimilar “ecosystem” that will keep federal dockets busy with litigation for the foreseeable future, according to a panel discussing trends in antitrust issues at the ACI 10th Summit on Biosimilars.
An increased number of biosimilar applications have been filed that target extremely successful reference products, noted Vernon M. Winters, JD, of Sidley Austin LLP. It is speculated by industry observers that there are 10 applications pending at the FDA, he said.
As of the end of May, there have been 32 cases filed under the Biologics Price Competition and Innovation Act (BPCIA), although many concerned BPCIA disclosure and patent dance obligations, or what he called “procedural skirmishes,” he said. While outright “pay-for-delay” settlements are on the decline, he said, citing a report from the Federal Trade Commission, outright patent litigation is clearly part of the biosimilar environment.
Winters also discussed the 2016 Supreme Court divided ruling in FTC v Actavis that a brand-name drug maker’s payment to a generic competitor to settle patent litigation can violate antitrust laws.
Under that ruling, a dozen or so lawsuits have been filed against AbbVie over its blockbuster brand-name adalimumab, Humira, for alleged use of a patent thicket to maintain a monopoly. The lawsuits include those from various unions, who allege that they have paid artificially high prices.
In addition, Nicholas Groombridge, JD, of Paul, Weiss, Wharton & Garrison LLP, discussed the issues surrounding the Pfizer Inc v Johnson & Johnson antitrust suit over Johnson & Johnson’s originator infliximab (Remicade). The suit, filed in September 2017, alleges that Johnson & Johnson engaged in exclusionary contracts, bundled rebates, and multiproduct bundling practices related to its originator infliximab that have effectively denied patients access to biosimilar therapies (including Pfizer’s Inflectra) and have undermined price competition in the biologics marketplace.
Discovery in the case is ongoing, he said, with more than 170 nonparty subpoenas and ongoing disputes over the scope and timing of discovery.
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.
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.
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.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.