| |DECEMBER 20248BIOCON BIOLOGICS BAGS GLOBAL ENTRY FOR BIOSIMILAR USTEKINUMAB IN KEY MARKETSSURGICAL IMPORTS SURGE TO $621.59M IN FIRST HALF OF FISCAL YEARBiocon Biologics, a branch of Biocon, has gained access to the market for the biosimilar Ustekinumab in Europe, the United Kingdom (UK), Canada, and Japan. Ustekinumab is a human monoclonal antibody that inhibits the irregular regulation of interleukin IL-12 and IL-23 related immune disorders.The company has obtained approval from the USFDA to introduce the biosimilar version of Janssen's Stelara (Ustekinumab), which is utilized in treating autoimmune conditions like Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.According to the settlement and licensing agreement with Janssen, Biocon Biologics is expected to introduce the drug in the US by February 22, 2025, at the latest. Stelara is the best-selling medication for Janssen, generating $7 billion in sales in the US for 2023. The biosimilar will be sold under the brand name Yesintek.The U.S. FDA has approved the evaluation of the company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) via the 351(k) pathway.The authorization will clear the path for the introduction of the biosimilar, contributing to the company's revenue and profitability, even with strong competition from competing biosimilars. The USFDA has granted approval to five biosimilars of Stelara, anticipated to enter the market in the fourth quarter of FY25.Amgen's biosimilar for Stelara is set to enter the global market, with a planned launch by January 1, 2025, at the latest. POIn the first half of the current fiscal year, imports of surgical products and equipment reached $621.59 million, an increase from the $557.68 million recorded in the same period last fiscal year. Imports increased by 13.03 percent in terms of 5,197.1 crore during the period of April through September, 2024, in comparison to 4,598.01 crore in the corresponding period of the previous financial year.In the quarter ending September 30, 2024, imports increased by 12.3%, reaching $332.78 million from $296.37 million in the previous fiscal year's corresponding period. Imports of surgicals increased by 13.8 percent. In terms of Rupees, 2,787.61 crore decreased year-on-year relative to 2449.6 crore is the equivalent phrase.In the fiscal year 2023-24, there was a 13.36 per cent increase in surgical imports, reaching $1.09 billion, up from $963.86 million in the previous fiscal year. Imports in Rupees increased by 16.8 percent to 9,046.5 crore in comparison to 7,743.25 crore recorded in the financial year 2022-23.During the fiscal year 2021-22, imports reached $894.21 million, showing a 60 percent increase from $557.52 million in the previous fiscal year. The imports in fiscal year 2020-21 decreased by 21 percent from $704.56 million in fiscal year 2019-20. POTOP STORIES
< Page 7 | Page 9 >