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How Risky Is Amgen's At-Risk Launch Of Herceptin, Avastin Biosimilars?

 
• By Brenda Sandburg

In ongoing patent litigation with Genentech, Amgen may need to reveal its counsel's advice on whether it should launch, while Genentech must produce its settlement agreements with Mylan, Celltrion, and Pfizer.

Courthouse Pillars & Stairs

Amgen Inc.'s decision to launch biosimilars to Genentech Inc.'s blockbuster cancer drugs Herceptin (trastuzumab) and Avastin (bevacizumab) is another indication that the 180-day notification provision created under the Biologics Price Competition and Innovation Act is essentially meaningless.

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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

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.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By Sue Sutter

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.