Biosimilar Substitution: 'Devil' Is In Barriers To Switch In State Laws

Brand and generic industries continue lobbying over provisions on ease of substitution; Utah is first state to remove sunset on pharmacist communication with physician. Interactive map and timeline detail key provisions and status of legislation in each state.

While the Generic Pharmaceutical Association and innovator companies settled a fierce feud over state legislation on biosimilar substitution, they continue to lobby over provisions that could affect how easy it is to make the switch from brand-name biologics to biosimilars.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legislation

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

 

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

 

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 

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.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By 

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

More from Pink Sheet

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By 

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.