1. Scrip
  2. >>New Products

Amgen Wins First EU Avastin Biosimilar Approval, But When Will It Launch?

 
• By Lucie Ellis-Taitt

Partners Amgen and Allergan have become the first biosimilar developers to win EU approval for a copycat version of Roche's Avastin; commercialization preparation is underway but predicting a launch date for the product is more complicated.

Fieldfare
Early bird gets the worm: Amgen/Allergan are first to win EU approval for Avastin biosimilar • Source: Shutterstocl

Amgen Inc.'sMvasi has won approval in Europe as the first biosimilar of Roche's best-selling cancer therapy Avastin (bevacizumab). This is the second time Amgen has been the first to gain approval of a critical biologic copycat product – but what are the benefits of being the early bird if you can't launch for several more years?

Following on from the EU approval of its Humira (adalimumab; AbbVie Inc.) biosimilar, Amgevita, in March 2017, Amgen has...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 
• By Edwin Elmhirst

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Stock Watch: When The Biotech Bandwagon Music Stops

 
• By Andy Smith

The number of viable biotech companies exploiting a particular technology should be limited by intellectual property but the number of biotech IPOs exploiting that same technology always seems greater than those with freedom to operate.

Lilly’s Muscle Builder Looks Strong In GLP-1 Obesity Combo

 
• By Andrew McConaghie

Bimagrumab added to Wegovy increased weight loss and preserved muscle mass, but analysts want to see more safety and efficacy results from a combination with Zepbound.

Mineralys Eyes NDA As Lorundrostat Scores CKD Win In Race With AstraZeneca

 
• By Sushmita Panda

As it races AstraZeneca’s baxdrostat to market, Mineralys plans to file an NDA later this year, backed by strong efficacy and safety data across four trials.