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Novartis AG (NVS) - free report >>
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Amgen (AMGN) Gets CHMP Nod to Expand EU Label of Neulasta
Biotech major Amgen Inc. (AMGN - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion to update the label of Neulasta to include Neulasta Onpro Kit, an innovative delivery system.
The Neulasta Onpro Kit combines a pre-filled syringe with a single dose of Neulasta and a single use on-body injector (OBI) delivery system.
Neulasta is used to prevent the chance of infection in patients with non-myeloid cancer who receive anti-cancer therapies.
The Neulasta Onpro Kit is an improved administration option for patients as it provides them an opportunity to administer the recommended dose of Neulasta at home, the day after chemotherapy, thereby saving a trip back to the doctor.
The kit has been available in the United States since 2015 while commanding a market share of about 60% in the United States for all Neulasta sales.
In 2017, Neulasta revenues declined 2% to $4.53 billion from the year-ago period due to lower demand. Increased competition from PD-1s and other new cancer therapies is hurting demand for Neulasta. While biosimilars are already hurting sales of Neulasta in the EU, it could start facing biosimilar competition in the United States this year.
Many companies are looking to get approval for biosimilar versions of Neulasta. However, three of these – Biocon/Mylan Coherus Biosciences, Inc. (CHRS - Free Report) and Novartis’ (NVS - Free Report) generic arm, Sandoz - have received complete response letters from the FDA for their applications to market a generic version of Neulasta.
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