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Biosimilars Could Give Brands the Boot Mid-Year Under Amendment Added to Senate PBM Reform Bill

 
• By Sarah Karlin-Smith

However, the low CBO score attached to the measure may suggest PBMs might not be incentivized to follow through on the congressional permission.

legs up in air with colorful cowboy coots in kicking motion
A measure to facilitate faster biosimilar coverage was added to the Senate Finance Committee PBM package. • Source: Shutterstock

Medicare Part D plans could switch the coverage status of a reference biologic midyear if the plan adds a biosimilar for that product to the formulary, under an amendment added to the Senate Finance Committee’s pharmacy benefit manager reform package, which cleared the committee on a 26-1 vote 26 July.

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Kiji CEO On EU HTA Regulation, Hospital Exemption & The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

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FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.