Lupin has been granted approval from Health Canada for its biosimilar Pegfilgrastim.

This product will be marketed under the brand name Armlupeg and manufactured at Lupin’s Biotech facility at Pune, India.

Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) 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, 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.”

Dr. 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 (pegfilgrastim) is a biosimilar comparable to the reference biologic drug NEULASTA (pegfilgrastim). It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. Armlupeg is available in a form of pre-filled syringe of 6mg/0.6 ml.

Lupin Ltd. is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.