United States: Food and Drugs Law

Accord BioPharma has secured FDA approval for ENNUMO, its second pegfilgrastim biosimilar referencing Amgen's NEULASTA, positioning the company as the only U.S. provider offering two distinct pegfilgrastim biosimilars alongside a short-acting G-CSF biosimilar. With eight pegfilgrastim biosimilars now approved by the FDA, the competitive landscape for these infection-reducing cancer treatments continues to expand. This approval strengthens Accord's biosimilar portfolio in the oncology supportive care market.

The U.S. Food and Drug Administration (FDA) published a notice in the Federal Register on July 7, 2026, announcing the availability of the draft commitments letter for the Medical Device User Fee Act for fiscal years...

Teva Pharmaceuticals and Polpharma Biologics have entered into a global licensing agreement for the commercialization of a biosimilar candidate to Genentech's OCREVUS (ocrelizumab), a treatment for multiple sclerosis. The agreement combines Polpharma Biologics' development expertise with Teva's commercial capabilities across major markets including the United States, Europe, and several other territories. Under the terms, Polpharma Biologics will handle development and manufacturing while Teva manages regul

The Federal Circuit examined whether a provisional patent application's disclosure of a C2-C12-alkyl group could support a later patent claiming a C1-C12-alkyl structure, when an intervening public disclosure by a competitor revealed the C1-alkyl compound. The court's decision hinged on whether alleged typographical errors in the provisional application could establish written description support for the broader claim scope.

The U.S. Supreme Court's unanimous June 4, 2026, decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, clarified the standard for induced patent infringement under 35 U.S.C. § 271(b).

The FDA has granted interchangeability designation to TRUXIMA® (rituximab-abbs), making it the first rituximab biosimilar to achieve this status in the United States. This milestone allows pharmacists to substitute TRUXIMA® for the reference product RITUXAN® without prescriber intervention, potentially expanding access to this treatment for conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

The U.S. Supreme Court's decision in Monsanto Co. v. Durnell establishes that federal pesticide labeling authority preempts state failure-to-warn claims when EPA has determined specific warnings are not required. This landmark ruling arrives amid a flurry of Trump Administration executive orders and EPA initiatives reshaping pesticide policy, from glyphosate supply chain protections to $30 million in funding for chemical alternatives. The decision's implications extend beyond Roundup litigation to fundament

In a high-stakes patent dispute over Pfizer's blockbuster COVID drug Paxlovid, Enanta Pharmaceuticals discovered that a single carbon atom—allegedly a typographical error in their provisional patent application—stood between them and billions in potential damages. The case explores whether courts will rescue a patentee from its own written words when the difference between "C₁" and "C₂" means the difference between patent rights and public domain, raising fundamental questions about

The U.S. FDA has approved LUMVOA (veligrotug-vvze) as the first treatment for thyroid eye disease with labeling that includes data from both active and chronic patient populations. This milestone marks Viridian Therapeutics' first FDA-approved medicine and commercial product, offering a new therapeutic option for patients suffering from this rare autoimmune disease characterized by inflammation and tissue remodeling around the eyes.