Lupin obtains Health Canada approval for Neulasta biosimilar
Lupin has received approval from Health Canada for pegfilgrastim, a biosimilar to Amgen's Neulasta. This product will be marketed under the brand name Armlupeg and manufactured at Lupin’s Biotech facility in Pune, India.
Pegfilgrastim is a pegylated form of the recombinant human granulocyte colony-stimulating factor analogue filgrastim. Pegfilgrastim prefilled syringes are indicated to decrease the incidence of infection, as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.
Nilesh Gupta, managing director at Lupin said, “We are committed to providing affordable and high-quality treatment to our patients. The Health Canada approval for Armlupeg strengthens our ability to support Canadian patients with this mainstay treatment.”
[Read more: Lupin receives FDA nod for 3 generics]
Cyrus Karkaria, president, biotech division said, “Biosimilars play an important role providing access to cancer treatment and supportive care. We are happy to receive our second biosimilar approval in Canada and look forward to maintaining this momentum with additional launches in regulated markets.”
Armlupeg is available in a form of pre-filled syringe of 6mg/0.6 ml.
[Read more: Lupin receives FDA OK for generic Banzel]