Swiss pharmaceutical Novartis announced Monday that a copycat version of Amgen’s Neulasta works just as well to prevent a condition that can lead to infection in women with breast cancer.
Neulasta stimulates white blood cell production in the body, which helps the body fight cancer. Novartis’ new drug is part of a new class of drugs called biosimilars, which are similar to generics but are made with living organisms and are not identical to the complex compounds they replicate.
Biosimilar drugs threaten multi-billion dollar profits made by large pharmaceutical and biotech drug makers. Proactive companies like Amgen also see opportunities though by potentially taking market share away from competitors’ drugs by developing their own biosimilars.
Novartis’ biosimilar to Neulasta was submitted to the FDA for approval in November. If approved, it could dent Amgen’s bottom line. Neulasta had $4.6 billion in sales last year.
The study showed that there were no clinically meaningful differences between the proposed biosimilar pegfilgrastim and the reference product,” Novartis said in a news release. “Adverse events were similar and consistent with the known safety profile of pegfilgrastim.
• Contact Philip Joens at [email protected].