Biocon shares gained for the third consecutive session, trading at ₹384.55, down 0.6% as of Friday, September 25. According to Business Standard, the stock has demonstrated strong momentum with 8.91% gains over the last one year, significantly outperforming the 7.1% drop in NIFTY and the 20.91% decline in the Nifty Pharma index. The positive performance comes as the benchmark NIFTY is up 0.29% at 23,413.6 and the Sensex trades at 74,819.64, up 0.71% on the day. However, the stock has slipped around 3.66% in the last one month, with trading volume of 22.73 lakh shares compared to the daily average of 32.57 lakh shares in the last month.
Biocon Biologics has achieved a historic milestone by becoming the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's tailored clinical development approach. According to the latest exchange filing, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the granting of a marketing authorisation to its Pertuzumab biosimilar. The positive opinion covers the biosimilar as a 420 mg concentrate solution for infusion, marketed under the brand name Pebrilzo® for the treatment of HER2-positive breast cancer across multiple disease stages. As per the regulatory filing, this marks the first time a monoclonal antibody biosimilar has received a positive CHMP opinion under the EMA's tailored clinical development approach, reflecting an important milestone in the evolution of biosimilar science.
Shreehas Tambe, CEO & Managing Director of Biocon, emphasized the significance of this achievement, stating that the positive CHMP opinion marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe. As Tambe noted, this milestone reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence on advanced analytical and clinical pharmacokinetic evidence to establish biosimilarity. The positive opinion follows the review of the marketing authorization application submitted by Biocon Biologics Ireland Limited (formerly Biosimilar Collaborations Ireland Limited), which is an indirect wholly-owned subsidiary of Biocon Biologics Limited. The European Commission will now conduct a final review of the application before making its decision, with the Summary of Product Characteristics (SmPC) becoming available in all official European Union languages following a positive decision.
Pebrilzo® is a biosimilar medicinal product containing Pertuzumab, a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2. The biosimilar is indicated for combination use with Trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence, as well as in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. Additionally, it is indicated for use in combination with Trastuzumab and Docetaxel in adult patients with HER2 positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. According to the regulatory filing, extensive orthogonal, state-of-the-art structural and functional analytical characterisation, along with comparative clinical pharmacokinetic data, demonstrated that Pebrilzo® is highly similar to the reference biologic with no clinically meaningful differences in quality, safety, or efficacy.
Biocon reported robust first quarter earnings last month, with net profit surging to ₹141 crore from ₹31.4 crore last year, while revenue increased 16% to ₹4,336 crore from ₹3,942 crore in the first quarter last year. The company's EBITDA increased 10.6% to ₹847.2 crore from ₹766.1 crore, with margins expanding to 19.54% from 19.43% in the year-ago period. According to CNBC-TV18, Biocon MD and CEO Shreehas P Tambe indicated that the company's insulin business can reach the $1 billion revenue mark soon, citing strong demand for insulin and traction for newer products such as aflibercept supporting growth. Beyond insulin, the company has a portfolio of over 30 biosimilars, including newer products like Aflibercept and established ones such as trastuzumab and pegfilgrastim. The company is expecting double-digit revenue growth in biosimilars, while targeting margins in the mid-20% range.
