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Antitrust Issues Surrounding Biosimilars, Originator Products Not Going Away Anytime Soon
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
