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Humira Biosimilar Interchangeability: The Race Begins

 
• By Derrick Gingery

Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.

Identical twins
Is pink interchangeable with yellow?

Boehringer Ingelheim GMBH became the first company to publicly disclose the start of a biosimilar interchangeability trial since the US FDA issued draft guidance on the subject, displaying a fair bit of confidence in a product the agency hasn't even approved yet.

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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

Stelara Biosimilars Storm US Market With 85% Discounts Ahead Of Price Drop In Medicare

 
• By Cathy Kelly

The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.

Belgian Body Hits Out At Roche For Delaying Biosimilar Competition

 
• By Dave Wallace

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

More from Biosimilars & Generics

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

 
• By Vibha Ravi

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?

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Is Optum Rx Payment Remodel To Favor Generics A Peace Offering For US FTC?

 
• By Urtė Fultinavičiūtė

Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.