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India-based firm Lupin has joined the pegfilgrastim parade with the FDA’s approval of Armlupeg (pegfilgrastim-unne), the seventh biosimilar for Amgen’s Neulasta approved in the US since 2018.
Like Neulasta, Armlupeg is approved as a 6 mg/0.6 ml subcutaneous injection to reduce infections in patients with nonmyeloid cancers who are undergoing myelosuppressive chemotherapy and to improve survival after myelosuppressive radiation doses, Lupin announced in a press release. Pegfilgrastim stimulates the production of white blood cells.
In a November 8 press release, Lupin said its Pune, India, manufacturing plant had passed a recent FDA inspection.
Approval was based on data that included a phase 3 clinical study with 86 nonmyeloid cancer patients randomized to Armlupeg and 84 randomized to Neulasta. Patients in the Armlupeg group spent an average of about 3 hours in severe neutropenia during their first chemotherapy cycle vs 4.7 hours in the Neulasta group; the difference wasn’t statistically significant.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
