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Mylan Poised To Launch Its First US Biosimilar, With A Stacked Pipeline Behind It

 
• By Jessica Merrill

A biosimilar of Amgen's Neulasta appears on track for FDA approval by the June 4 action date, management said during an investor briefing that showcased Mylan's expansive biosimilar pipeline. Mid- to late-stage copies of products like Advair, Symbicort, Herceptin, Humira, Avastin, Rituxan, Eylea and Botox highlight the strategic direction Mylan moved in nearly a decade ago. 

Mylan HB Investor Day
Mylan CEO Heather Bresch presents to investors • Source: Mylan

Mylan NV has developed an impressive pipeline of biosimilars, but whether it can turn those products into commercial successes on the big stage that is the US market remains a question. Now, after many years of investment, the company seems close to getting the chance to launch its first biosimilar in the US, a version of Amgen Inc.'s Neulasta (pegfilgrastim).

Mylan showcased its biosimilar pipeline during an investor day in New York City April 11. The company has 11 biosimilar...

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