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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 products, including insulins, in clinical development through partnerships with

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