India’s largest biopharmaceutical firm Biocon announced that consolidated net profit rose 47% for the three months ended June 30 compared with the year-earlier period driven by growth in its biologics and research services business.
“We started the year with a robust Q1FY19, recording an overall revenue growth of 21% at ₹1,193 crore and a 47% increase in net profit at ₹120 crore, driven by a strong performance across our business segments,” chairperson and MD, Kiran Mazumdar-Shaw, said.
“This performance was led by a 36% growth in our biologics business and a 39% increase in research services revenues.
“The approval and introduction of biosimilar Pegfilgrastim, FulphilaTM, in the U.S. is a significant milestone for Biocon and sets the tone for the future success of our biosimilars business,” she added.
The CGMP approvals for Biocon’s drug products manufacturing facility in Bengaluru by both the U.S. FDA and EMA demonstrates the company’s commitment to providing high-quality products to address the growing needs of patients for affordable biosimilars in these markets. “These developments augur well for a strong financial performance in FY19,” she said.
The biologics segment comprises of novel biologics and biosimilars and was driven by higher sales of biosimilar monoclonal antibodies (mAbs) in emerging markets, supported by Insulins business.
During the quarter, the firm’s insulin portfolio gained market share in several emerging markets such as Malaysia, Algeria, and the UAE. Its brand Insugen, now holds a 75% share of the rh- insulin market in Malaysia, according to a company statement.
During the quarter, Biocon made several regulatory submissions for Insulin Glargine in CIS (Commonwealth of Independent States) and MENA (the Middle East & North Africa) regions.
For the U.S. market, Biocon and its partner Mylan are generating additional clinical data for insulin Glargine in support of the manufacturing site change from Bengaluru to Malaysia.
All activities as agreed with the USFDA in this regard are progressing as planned and we will expeditiously provide the requested data to the regulator in response to the Complete Response Letter (CRL) we received for Insulin Glargine. “We do not anticipate any impact on the approval and launch timing of Insulin Glargine in the U.S,” according to the statement.
The research business through Syngene sustained its strong growth trajectory, reporting a revenue growth of 39% at ₹406 crore, buoyed by the performance of discovery and development services for small molecules and continued traction in the biologics business, it stated.
