Big Molecule Watch
August 25, 2021

Enzene Biosciences Announced Romiplostim Approval in India

Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim.  The product will be offered in three dosage strengths and is indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.  ITP is a hematological disorder involving low platelet levels, with symptoms including increased tendencies for bruising and bleeding.  Dr. Himanshu Gadgil, Whole Time Director of Enzene, which is a subsidiary of Alkem Laboratories Ltd., said:  “With the approval of Enzene’s Romiplostim drug in India, we are happy to bring this life-saving therapy to ITP patients.  Enzene is now actively developing strategic partnerships to further expand global access to this therapy.”

Romisplostim is Enzene’s second approved biosimilar in India, following the approval and launch of its teriparatide product earlier this year.

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