Novartis ($NVS) is moving toward the U.S. market with a biosimilar of Amgen's ($AMGN) Neulasta, awaiting FDA approval for a long-acting treatment designed to boost white blood cell count.
Through its Sandoz subsidiary, Novartis submitted its version of Amgen's therapy, generic name pegfilgrastim, and the agency accepted the application, triggering a 10-month review period. Neulasta is a long-acting version of Amgen's own Neupogen, and the two products brought in a combined $5.8 billion for the company last year, accounting for nearly 30% of total sales.
The Neulasta copy marks Novartis' third stateside biosimilar submission, each targeting an Amgen drug. The Swiss drugmaker scored the U.S.'s first biosimilar approval this year with Zarxio, a Neupogen knockoff launched in September. Last month, the agency accepted Novartis' application for a copy of Amgen's top-selling Enbrel, a treatment for rheumatoid arthritis and other autoimmune diseases that cleared about $4.8 billion in sales last year.
Zarxio's launch marked a milestone expected to help knockoff biologics bring in more than $35 billion by 2020 as more and more treatments lose patent protection, analysts say. Among the most common targets are Johnson & Johnson's ($JNJ) Remicade, Roche's ($RHHBY) Herceptin and AbbVie's ($ABBV) Humira.
Novartis has dubbed itself the leader among companies looking to cash in on patent expiries, with 10 planned biosimilar filings over the next three years.
Amgen, on the other hand, is working to soften the blow of coming biosimilar competition by developing copycats of its own. This year, the company is planning to submit a biosimilar of Enbrel rival Humira for FDA approval, and it has teamed up with Allergan ($AGN) on biosimilars of Eli Lilly's ($LLY) Erbitux and Roche's Avastin, Herceptin and Rituxan. On its own, Amgen is developing a version of Remicade and three more as-yet-undisclosed programs.
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