Enzene Biosciences Romiplostim gets DCGI marketing authorization
Romiplostim, a therapeutic fusion protein, acts as a thrombopoieses stimulating factor, thereby restoring platelet levels and ameliorating the disease.
New Delhi: Enzene Biosciences Ltd. "Enzene" announced a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug "Romiplostim", indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.
In doing so, Enzene becomes the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg).
ITP is a rare haematological disorder (prevalently autoimmune) with a primary clinical presentation of aberrantly low platelet levels, and symptoms including an increased bruising and bleeding tendency.
Romiplostim, a therapeutic fusion protein, acts as a thrombopoiesis stimulating factor, thereby restoring platelet levels and ameliorating the disease. As such, it remains one of the most reliable long-term treatment options for ITP patients.
According to Dr. Himanshu Gadgil, Enzene's Whole Time Director, "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."
Fresh off the launch of Enzene's first biosimilar Teriparatide (indicated for the treatment of osteoporosis) earlier this year, Sandeep Singh, Managing Director, Alkem Laboratories Ltd., said, "Alkem's long-standing primary mission to provide widespread affordable access to medicines in the Indian pharmaceutical market has received a huge boost today with our subsidiary Enzene's second biosimilar launch within the year. Alkem has built an exceptional strength in the clinical research and testing group and we remain dedicated as ever, to bringing many such therapies in the near future."