Biosimilar Interchangeability: A Blessing Or A Curse?

As Industry Awaits First FDA Decision, Views Are Mixed On Interchangeability

Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.

Swap flip interchangeable icon
Opinions differ across the biosimilars industry on interchangeability

When the US Biologics Price Competition and Innovation Act set out the country’s biosimilars framework in 2009, it contained within it a significant provision that would set the US apart from other markets in its treatment of biosimilarity, in the form of an additional designation for “interchangeable” biosimilars.

Interchangeability is defined by the BPCIA as a separate standard to biosimilarity, and requires a product to not only be...

More from Market Access

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By 

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By 

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

US Health System Redesign Critical, NAM’s Medical Experts Warn Trump Government

 
• By 

The whirlwind back-and-forth on US tariffs and Robert F. Kennedy jr.’s plans to deregulate health care have become all-preoccupying, but the National Academy of Medicine was first to set out President Trump’s health administration priorities.

Future Of 340B Rebate Models Hinges On Regulatory Decision Point

 
• By 

As pharmaceutical companies seek to transform how drug discounts are delivered under the 340B program, a federal ruling reinforces HRSA's authority. The industry must now wait for critical guidance from the Trump administration that could reshape compliance strategies and financial outcomes.

More from In Vivo