Page 8 - Biocon

Not evaluating any divestment options for API business, says Biocon

Biotechnology major Biocon on Friday said it is not evaluating divestment options for its API business. In a regulatory filing, Bengaluru-based company said it is "neither evaluating any divestment options for its API business nor consulting any bankers for this." The Active Pharmaceutical Ingredient (API) business is a strategic business segment of the company and a key growth driver for the company's small molecules business, a company spokesperson said. "Biocon continues to strengthen this business and has an ongoing investment of over half a billion dollars in capex and R&D," the filing said. The company has a strong pipeline of niche fermentation-based APIs, peptides and high potent API products for the near- and long-term growth of its integrated APIs and generic formulations business, it said. Biocon shares on Friday ended 1.25 per cent down at Rs 251.60 apiece on the BSE.

Biocon considers selling generic API biz; turn into biosimilar major

The generic API business has been one of the primary businesses for Biocon, however, in recent years, the segment's contribution towards the company's consolidated financials has declined

Biocon Biologics integrates Viatris' biosimilar biz in 31 European nations

Biocon Biologics on Thursday said it has completed the integration of the acquired biosimilar business from Viatris Inc in 31 European countries. Following the deal closure in November 2022, the company, a unit of Biocon Ltd, had earlier announced the integration of Viatris Inc's business in over 70 countries in emerging markets, effective July 1, 2023, and North America in September 2023. "The integration of the Viatris biosimilar business in Europe ahead of schedule is another important milestone for Biocon Biologics in our journey as a global biosimilar leader. We are pleased to expand access to lifesaving treatments for patients across Europe," Biocon Biologics CEO and MD Shreehas Tambe said in a statement. The pipeline of 20 products will allow the company to better address patient needs and be a reliable partner to health organisations, he added. Biocon Biologics and its partners will commercialise biosimilar products in various European countries like Albania, Austria, Belgi

Biocon biologics receives marketing approval by MHRA for YESAFILI in UK

This approval follows the green light granted by the European Commission (EC) for marketing authorisation in the European Union (EU) back in September

Biocon Biologics gets marketing authorisation for biosimilar from MHRA

Biotechnology firm Biocon on Monday said its unit has received marketing authorisation for a biosimilar product from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Biocon Biologics has received marketing authorisation for Yesafili, a biosimilar of Aflibercept, the Bengaluru-based company said in a regulatory filing. Yesafili, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) age-related macular degeneration among other issues. It is highly similar to the reference product Eylea (aflibercept). "This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios," a company spokesperson said. As per IQVIA sales data, Aflibercept brand sales in the UK stood at USD 790 million.

Biocon jumps 4% on the back of strong Q2 performance

The stock had shed 16 per cent in Samvat 2079. So far in 2023, the stock has declined 9 per cent as against a near 7 per cent gain on the BSE benchmark.

Biosimilars growth props up Biocon Q2 PAT by 168% to Rs 126 crore

On a sequential basis, the company exhibited a 1.15 per cent increase in revenue along with PAT, which rose 23.8 per cent

Biocon Q2 results: Net profit zooms over two-fold to Rs 173 crore

Biotechnology major Biocon on Friday said its consolidated net profit rose an over two-fold to Rs 173 crore for the second quarter ended September 30, 2023. The company had reported a net profit of Rs 82 crore for the July-September period of the last fiscal. Total income rose to Rs 3,620 crore for the second quarter as against Rs 2,384 crore in the year-ago period, Biocon Ltd said in a regulatory filing. Shares of the company on Friday ended 0.11 per cent higher at Rs 227.35 apiece on the BSE.

Biocon Biologics appoints Kedar Upadhye as new chief financial officer

Current CFO, MB Chinappa will take on a strategic finance role at Biocon Group

Official action indicated for Biocon arm's unit in Malaysia after FDA probe

Biocon Ltd on Wednesday said the US health regulator has classified as 'official action indicated' for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in a regulatory filing. "Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Ltd, has received a communication from the US Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia," a company spokesperson said in the filing. The USFDA has "determined the inspection classification as 'OAI' (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility", the spokesperson added. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product

USFDA rejects proposed Biocon's Insulin Aspart application in CRL

Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin Aspart, a proposed biosimilar for diabetes treatment. The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form. "The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022," Biocon spokesperson said in a regulatory filing. The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022 that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility prior to the approval of the ..

Biocon, Juno Pharma ink pact for commercialisation of Liraglutide in Canada

Under the agreement's terms, Biocon will be responsible for obtaining regulatory approvals for Liraglutide and will subsequently manage the manufacturing and distribution of the product within Canada

Biocon Biologics gains EU approval for Aflibercept biosimilar, YESAFILI

According to market research firm IQVIA, Aflibercept generated about $1.8 billion in annual sales in the EU in 2022

Stocks to Watch: RIL, RR Kabel, Tata Motors, Bank of Maha, Bharat Dynamics

Stocks to Watch today, September 20, 2023: RR Kabel is set to debut at the stock exchanges on Wednesday, becoming the first entity to make a T+2 listing

Drugmaker Biocon appoints Peter Bains as group CEO effective immediately

Bains, who was named as an independent director of the Biocon board in December last year, stepped down on Monday to assume the top charge, the company said in a statement

Biocon Biologics completes integration of Viatris biosimilars business

Biocon on Wednesday said its arm Biocon Biologics has completed the integration of the acquired biosimilars business from Viatris in North America with effect from September 1, 2023. Since the acquisition agreement closed in November 2022, Biocon Biologics has executed a robust integration plan to ensure a seamless transition of partners, people, systems, and processes, Biocon said in a regulatory filing. In February 2022, Biocon Biologics had inked a pact to acquire Viatris Inc's biosimilars business for a consideration of up to USD 3.33 billion (about Rs 24,990 crore). Later, in November same year the company completed the acquisition. "Our successful North America (US and Canada) transition marks the second wave of our integration of the Viatris biosimilars' business, quickly following Emerging Markets and ahead of schedule," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said the company would be leading the commercial operations in the US and Canada

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Stocks to Watch on Aug 14: Adani Ports, Nykaa, Raymond, PSU Banks, Biocon

Stocks to watch on August 14, 2023: Balrampur Chini, Delta Corp, Indiabulls Housing Finance, India Cements, Manappuram Finance and Zee among nine stocks in F&O ban period on Monday.

Biocon Biologics set to integrate Viatris' biosimilars biz ahead of plan

BBL is actively working on raising funds from private equity investors to retire part of the $1.4 billion debt that was incurred due to the acquisition

Biocon Q1 results: Consolidated net profit falls 11% to Rs 148.9 cr

Biocon Ltd on Thursday reported an 11 per cent decline in consolidated net profit at Rs 148.9 crore in the first quarter ended June 30, 2023. The company had posted a consolidated net profit of Rs 167.4 crore in the same quarter last fiscal, Biocon Ltd said in a regulatory filing. Consolidated revenue from operations during the quarter under review stood at Rs 3,422.6 crore as compared to Rs 2,139.5 crore in the corresponding period a year ago, it added. Total expenses were higher at Rs 3,299.2 crore in the first quarter as against Rs 1,977.5 crore in the year-ago period, the company said. On a standalone basis, Biocon said its net profit was at Rs 46.6 crore, up from Rs 14.9 crore in the same quarter previous fiscal. Standalone revenue from operations stood at Rs 513.2 crore as compared to Rs 441.7 crore in the year-ago quarter, the filing said. The company said its board approved the appointment of Nicholas Robert Haggar as an Additional Non-Executive, Independent Director sub