United States: Food, Drugs, Healthcare, Life Sciences

Mintz’s Managed Care, PBMs & Pharmacies Practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This issue examines key federal and state developments from mid-February 2026 through June 2026 impacting PBMs and the broader prescription drug supply chain.

The U.S. Environmental Protection Agency has launched a new email subscription feature for its Bulletins Live! Two system, enabling pesticide users to receive real-time updates on geographically specific use limitations designed to protect endangered species. This development addresses longstanding requests from agricultural stakeholders who need timely access to evolving Pesticide Use Limitation Areas that can change between the time they pull compliance documentation and their actual application dates.

STADA and Sino Biopharmaceutical Limited have formed a strategic partnership to develop and commercialize biosimilar medications across Europe and neighboring regions. The collaboration focuses on bringing biosimilar alternatives to market, beginning with a pembrolizumab biosimilar targeting multiple cancer indications, with plans to expand into additional oncology and immunology treatments.

Mintz’s Managed Care, PBMs & Pharmacies Practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This issue examines key federal and state developments from mid-February 2026 through June 2026 impacting PBMs and the broader prescription drug supply chain.

A federal court in Delaware has granted Janssen's motion for a preliminary injunction against Accord BioPharma and Bio-Thera Solutions, halting the manufacture, sale, and importation of their golimumab biosimilar BAT2506 in the United States. The injunction requires Janssen to post a $98.8 million bond while the underlying patent dispute continues through litigation and inter partes review proceedings at the USPTO.

STADA and Sino Biopharmaceutical Limited have formed a strategic partnership to develop and commercialize biosimilar medications across Europe and neighboring regions. The collaboration focuses on bringing biosimilar alternatives to market, beginning with a pembrolizumab biosimilar targeting multiple cancer indications, with plans to expand into additional oncology and immunology treatments.

PHI Health LLC has filed suit against Anthem, alleging that the insurer and health plans it administers have failed to pay about $30 million in final payment determinations issued under the No Surprises Act (NSA)’s independent dispute resolution (IDR) process. The suit, which PHI filed in an Indiana federal district court, seeks over $1.3 million in interest on the payments that Anthem is accused of withholding.

State legislatures are moving beyond simple physician noncompete bans to create diverse regulatory frameworks addressing workforce mobility, market concentration, and patient access across the entire healthcare spectrum. From profession-based protections to conditional restrictions and staffing intermediary oversight, these emerging models reflect a fundamental shift in how states view healthcare labor markets as distinct from ordinary employment relationships.

Companies seeking to enter the United States medical device market must first determine whether their product qualifies as a medical device and define its intended use, which helps determine how the United States Food and Drug Administration (FDA) will regulate and classify the product.