Biosimilars continue to make a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a
On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed at dramatically reducing the cost and timeline of biosimilar development (U.S. Food and Drug Administration,FDA Moves to Accelerate
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted for approximately half of U.S. healthcare medicine spending in the past few years. While biosimilars have offered
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more affordable
On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi (collectively “defendants”) (DNJ No. 23-cv-22485). The plaintiffs allege that the defendants infringe or intend to infringe fifteen patents related to the biologic rituximab
As one BPCIA case came to a close in May[1], another got underway. On May 1, 2023, Amgen filed a complaint in the District of New Jersey, accusing Sandoz of infringing patents that relate to denosumab, the active ingredient in Amgen’s PROLIA and XGEVA. PROLIA is prescribed for a high risk of bone
On Tuesday, May 23, 2023, Janssen and Amgen settled their case regarding Amgen’s proposed biosimilar to Stelara in Delaware district court.[1]
Stelara, also known as ustekinumab, is an anti-IL-12/IL-23 antibody drug used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Amgen has created a biosimilar of Stelara called ABP 654, which
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are highly similar to existing biological products and are designed to be as effective and safe as the brand name drugs, offer the potential to provide
On September 27, 2022, Judge Richard Andrews of the District of Delaware granted Novartis’s motion to dismiss declaratory judgment (“DJ”) counterclaims raised by two generic drug manufacturers in the ongoing litigation regarding Novartis’s heart failure medication, Entresto® (sacubitril/valsartan).[1] The decision provides guidance to ANDA applicants seeking to maintain a case or controversy for DJ