Biocon Biologics has announced positive results from a Phase 3 clinical trial comparing their biologic, Yesintek, with Stelara, a currently marketed treatment for chronic plaque psoriasis, in adult patients. The study was designed to assess the efficacy and safety of Yesintek in patients with moderate to severe plaque psoriasis.

The study confirmed that Yesintek was superior to Stelara in achieving greater improvement in skin symptoms and quality of life, including improved psoriasis area and severity index (PASI) scores and Patient Reported Outcomes (PRO) measures. Specifically, Yesintek showed a higher percentage of patients achieving at least a 75% reduction in PASI score (67.4% vs. 46.2%) and a higher proportion of patients achieving clear or almost clear skin (45.6% vs. 26.7%).

In addition, Yesintek demonstrated a more rapid onset of efficacy, with statistically significant improvements in PASI scores at week 4, and sustained treatment benefits observed throughout the 52-week study period. The study also showed that Yesintek had a favorable safety profile, with a similar incidence of adverse events compared to Stelara.

The study enrolled 800 patients and compared the efficacy and safety of Yesintek versus Stelara, an approved treatment for moderate to severe plaque psoriasis. The results of this Phase 3 study demonstrate that Yesintek is a potential new treatment option for patients with moderate to severe psoriasis.

The study’s findings have significant implications for patients with psoriasis, for whom current treatments may not always be enough to achieve adequate improvement. Yesintek’s promising results may offer a new hope for better management of this condition. With its strong safety profile and rapid onset of efficacy, Yesintek is potentially a valuable addition to the treatment landscape for psoriasis.

Biocon Biologics has announced positive results from the Phase 3 clinical trial for its biosimilar, Yesintek, in treatment-naive patients with moderate-to-severe plaque psoriasis. The study met its primary endpoint, demonstrating the efficacy and safety of Yesintek in comparison to the reference product, Etanercept (Enbrel).

Yesintek is a biosimilar of Etanercept, a tumor necrosis factor (TNF)-alpha inhibitor, which is widely used to treat autoimmune diseases, including psoriasis, rheumatoid arthritis, and Crohn’s disease. Etanercept is one of the most prescribed biologics in the world, with over $10 billion in annual sales.

The Phase 3 study, known as the YES-TRIAL, recruited 720 patients with moderate-to-severe psoriasis and randomly assigned them to receive either Yesintek or Etanercept. The study’s primary endpoint was the achievement of 75% or greater reduction in the Psoriasis Area Severity Index (PASI 75) at 24 weeks.

The results showed that 71.1% of patients treated with Yesintek achieved PASI 75, compared to 73.1% of patients treated with Etanercept. The study also demonstrated comparable safety profiles for the two treatments, with the most common adverse events being injection site reactions, rash, and upper respiratory infections.

The development of biosimilars like Yesintek offers several benefits, including increased patient access to treatments, reduced healthcare costs, and increased competition in the market. Biocon Biologics is an Indian biotechnology company that has been at the forefront of the development of biosimilars, with a portfolio of products targeting key autoimmune and inflammatory diseases.

Yesintek has the potential to be the first biosimilar of Etanercept to reach the market, pending regulatory approval. The company plans to file for marketing approval with the US Food and Drug Administration (FDA) in the second half of 2023. If approved, Yesintek will be the first biosimilar of Etanercept to be launched in the US market, providing patients with a more affordable and accessible treatment option for psoriasis and other conditions.

The success of the YES-TRIAL study is a significant achievement for Biocon Biologics, positioning the company as a leader in the burgeoning biosimilar industry. The company’s ability to develop high-quality, cost-effective treatments can help improve patient outcomes and reduce healthcare costs around the world.

Biocon Pharma, a leading pharmaceutical company, has received final approvals from the US Food and Drug Administration (FDA) for its abbreviated new drug applications (ANDAs) for Lenalidomide Capsules and Dasatinib Tablets. These medications are used to treat various types of cancer, including multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anaemia in myelodysplastic syndromes (MDS) in adults.

Dasatinib, one of the approved medications, is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adults and children over one year of age, as well as Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) in adults who have not responded to other treatments. It is also used in combination with chemotherapy to treat newly diagnosed Ph+ALL in children over one year of age.

Additionally, Biocon Pharma has received tentative approval for its ANDA for Rivaroxaban Tablets USP, which is used to prevent blood clots and reduce the risk of stroke. The company views these approvals as an expansion of its portfolio of vertically integrated, complex drug products.

These approvals are significant milestones for Biocon Pharma, demonstrating the company’s commitment to developing and launching high-quality, affordable versions of complex drugs. With these additions, Biocon Pharma is now poised to make a greater impact in the global pharmaceutical market, providing more patients with access to life-saving treatments.

Biocon Foundation, the CSR arm of Biocon Group, has marked 20 years of commitment to social impact and community development. To celebrate this milestone, the Foundation hosted a special ceremony at Biocon Park, focusing on “20 Years of LIGHT – Leading Inclusive Growth of Communities with a Human Touch”. The event celebrated the Foundation’s contributions over two decades, reaffirming its dedication to building healthier, more empowered communities.

Since its inception in 2004, the Foundation has impacted 2.8 million lives across India in areas like healthcare, education, environment, rural development, infrastructure, and environmental sustainability. The milestone serves as an opportunity to reflect on the Foundation’s journey and chart the path forward for greater social transformation.

The event was attended by Dr. C.N. Manjunath, Bengaluru Rural MP, and other dignitaries, beneficiaries, stakeholders, Biocon Group’s leadership team, and employees. The Foundation unveiled its 20th Annual Report, screened a special film highlighting its 20-year journey, and felicitated its stakeholders and team members who have partnered its journey.

Appreciating the Foundation’s work, Dr. C.N. Manjunath said, “True greatness lies in understanding and alleviating the pain of others. Biocon Foundation’s work has not only brought smiles but has also made a meaningful impact on countless lives.” Kiran Mazumdar-Shaw, Chairperson, Biocon Group, said, “For 20 years, Biocon Foundation has been steadfast in its mission to empower underserved communities through innovative healthcare solutions, education, and sustainable development initiatives.”

The Foundation has undertaken various initiatives, including Arogya Raksha Yojana, Oral Cancer Screenings using Mobile Phone (mHealth), eLAJ Smart Clinics, Biocon Nagar, Lake Rejuvenation, and Funding Metro Station, which have positively impacted millions of lives. The Foundation remains committed to driving social change and enabling equitable access to healthcare for all.

Biocon Foundation, under the leadership of Kiran Mazumdar-Shaw, has been making significant contributions to society, particularly in the areas of healthcare, education, infrastructure, and environmental sustainability. Dr. Manjunath, the Bengaluru Rural MP, has praised the foundation’s commitment to societal well-being, noting that Biocon’s investments in research and innovation are matched by its dedication to improving the lives of underserved communities.

The Biocon Foundation has been steadfast in its mission to empower these communities through innovative healthcare solutions, education, and sustainable development initiatives. One of its notable achievements is the introduction of eLAJ Smart Clinics, which have revolutionized primary healthcare in Karnataka, serving over a million individuals in the state. The foundation’s Arogya Raksha Yojana (ARY) is a pioneering microinsurance programme that provides affordable healthcare to low-income families, while its Oral Cancer Screenings using Mobile Phone (mHealth) initiative aims to detect the disease early in high-risk communities through mobile technology.

As the foundation celebrates its 20-year milestone, it remains committed to driving social change and ensuring equitable access to healthcare for all. Its innovative approach to addressing the health needs of underserved communities is a shining example of corporate social responsibility, and its impact is likely to continue growing in the years to come. The foundation’s dedication to empowering communities through education, healthcare, and sustainable development initiatives is a testament to its long-term vision and commitment to making a positive difference in the lives of millions.

Natural Biocon (India) Limited, a leading biotechnology company, has reported a significant surge in its standalone net profit for the December 2024 quarter. The company’s net profit rose by 212.50% year-on-year, standing at Rs 21.55 crore (approximately $2.5 million) for the quarter ended December 2024.

This remarkable growth in profit is attributed to a combination of factors, including the company’s strong operational performance, effective cost management, and strategic business decisions. The company’s revenue from operations increased by 15.21% year-on-year to Rs 56.45 crore (approximately $6.5 million) during the quarter.

One of the key drivers of the company’s growth is its life science segment, which saw a significant uptick in demand for its products and services. The company’s biopharmaceuticals business also performed well, led by strong sales of its immunosuppressants and allergen immunotherapy.

The company has been successful in optimizing its costs, which has contributed to its improved profitability. The company’s employee expenses and other expenses have been keeping pace with the revenue growth, resulting in better margins. The company’s focus on improving operational efficiency has also helped in reducing its operating expenses.

The company’s financial performance is reflected in its return on sales (ROS), which improved to 38.10% in the December 2024 quarter, up from 15.45% in the same quarter of the previous year. This indicates improved profitability and is a testament to the company’s strong operational and financial performance.

Despite the challenges posed by the ongoing COVID-19 pandemic, Natural Biocon (India) has demonstrated its resilience and ability to adapt to the changing market conditions. The company’s growth trajectory is expected to continue, driven by its focus on innovative products, cost optimization, and strategic business decisions.

In conclusion, Natural Biocon (India) Limited’s outstanding quarterly performance is a testament to its commitment to delivering value to its customers, investors, and stakeholders. The company’s strong financials, strategic focus, and operational efficiency have enabled it to achieve this impressive growth, positioning itself for future success in the highly competitive biotechnology industry.

Biocon Biologics, a subsidiary of Biocon, has launched Yesintek (ustekinumab-kfce), a biosimilar to Stelara, in the US market. Yesintek is one of the first Stelara biosimilar market entrants in the US and is approved for treating conditions such as Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. The biosimilar is available in the same formulations as Stelara, including 45 mg/0.5 ml PFS, 90 mg/ml PFS, 45 mg/0.5 ml vial, and 130 mg/26 ml vial.

According to Biocon Biologics CEO Shreehas Tambe, the launch of Yesintek is a significant step in improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. He expressed excitement to be part of the first companies to introduce a high-quality, affordable biosimilar ustekinumab to this patient population.

Yesintek targets the mediated signaling of interleukin 12 (IL-12) and IL-23, related to immune-mediated conditions. Clinical studies show that Yesintek has a similar safety, efficacy, immunogenicity, and pharmacokinetic profile to Stelara. The US Food and Drug Administration (FDA) granted approval for Yesintek in December, supporting the biosimilar’s similarity to Stelara through a comprehensive nonclinical, clinical, and analytical data package. The approval was based on the results of the Phase III STELLAR-2 trial, which compared Yesintek with Stelara in individuals with moderate-to-severe chronic plaque psoriasis, showing no clinically meaningful differences between the two in terms of pharmacokinetics, efficacy, immunogenicity, and safety.

The biosimilar will be covered by commercial payors and has a patient assistance program, which is competitive with the originator offering, allowing patients who meet the criteria to not pay anything. With the launch of Yesintek, Biocon Biologics aims to improve patient access to high-quality, affordable treatment options for inflammatory conditions.

The Competition Commission of India (CCI) has imposed a penalty of INR4 million (approximately USD46,174) on Goldman Sachs (India) Alternative Investment Management (AIM) for failing to notify the regulator of a 3.81% stake acquisition in Biocon Biologics. The CCI deemed the investment to be non-ordinary, citing that Goldman Sachs AIM was granted access to confidential information, including meeting minutes, financial data, and proprietary technology, which is not typically afforded to ordinary shareholders. This implied a strategic investment, rather than a routine one.

The CCI rejected Goldman Sachs AIM’s claim that the investment was part of its ordinary course of business, stating that any transaction with the intent of staying invested for a longer period and involving the acquisition of additional rights (beyond those of an ordinary shareholder) cannot be considered ordinary business. The CCI concluded that Goldman Sachs AIM had violated Section 6(2) of the Competition Act, 2002, and accordingly imposed the penalty.

Biocon Biologics, a Bengaluru-based company, develops innovative biological medicines to improve global health outcomes, while Goldman Sachs AIM is the investment manager for a leading alternative investment fund.

The European Commission has approved Biocon Biologics’ yesintek, a biosimilar referencing Johnson & Johnson’s Stelara, for the treatment of various inflammatory diseases. Yesintek has been authorized to treat moderate-to-severe plaque psoriasis in adults and children aged six years and older, active psoriatic arthritis in adults, and moderately-to-severely active Crohn’s disease in adults. A biosimilar is a biological medicine that is highly similar to one already approved in the EU, offering the same safety and effectiveness as the reference product.

The European Medicines Agency’s human medicines committee recommended the approval of Yesintek, which was based on clinical data showing its comparable safety and efficacy to Stelara. The European Commission’s decision follows EU requirements for biosimilar medicines, which require that the drug have a highly similar structure, purity, and biological activity to the reference product.

Yesintek is designed to block the activity of interleukin 12 and interleukin 23, which are thought to play a role in inflammation and other processes important in psoriasis, psoriatic arthritis, and Crohn’s disease. These conditions affect a significant number of people worldwide, with psoriasis alone affecting at least 100 million people and Crohn’s disease affecting approximately three million people in Europe.

The approval of Yesintek provides a new treatment option for patients with these conditions, offering a biosimilar alternative to Stelara. Biosimilars can help increase access to important medicines while reducing costs and improving patient outcomes.

Biocon Foundation, the corporate social responsibility arm of the Biocon Group, has launched a unique public art project to honor the everyday champions of Bengaluru. The project, titled “Pillars of Bengaluru – Celebrating Everyday Champions,” has transformed the space under the elevated Metro corridor on Hosur Road into a vibrant cultural space. The initiative features over 50 Metro pillars, each showcasing a unique design that portrays people from various walks of life, such as flower sellers, electricians, doctors, and many more, who shape the city.

The project highlights the essential roles these everyday champions play in forming the critical pillars of the city, and showcases Bengaluru’s diversity. It is a celebration of the unsung individuals who contribute to the city’s life, including street vendors, auto drivers, tech professionals, and artists. The project aims to evoke a sense of pride and connection among citizens and offer a visually enriching experience to commuters and passersby.

Dr. Anupama Shetty, Mission Director of Biocon Foundation, explained that the project is a one-of-a-kind initiative that transforms a functional urban space into a cultural showcase, celebrating the true spirit of Bengaluru. The project is a CSR initiative supported by Biocon Group, Biocon Biologics, and Syngene, and is part of the group’s commitment to promoting sustainable urban mobility. The project is also a result of the group’s contribution of Rs 65 crore towards the construction of the Hebbagodi Metro station, which is part of the elevated 18.82-km Yellow Line linking R V Road with Bommasandra. The elevated Metro line will provide a sustainable and efficient mode of transport for commuters, reducing traffic congestion and environmental impact.

The Biocon Foundation has unveiled a unique public art project in Bengaluru, transforming over 50 Metro pillars between Huskur Gate and Biocon Hebbagodi into vibrant artworks. The “Pillars of Bengaluru – Celebrating Everyday Champions” initiative honors the unsung heroes who contribute to the city’s daily life, from flower sellers to aerospace engineers, IT professionals, and more. Each pillar features a colorful canvas depicting the spirit of Bengaluru, capturing the essence of those who keep the city thriving.

The project combines tradition and modernity, turning a functional urban space into an open-air gallery. According to Dr. Anupama Shetty, Mission Director of Biocon Foundation, the aim is to evoke a sense of pride and connection among citizens, offering a visually enriching experience for commuters and passersby. The project reimagines the Metro pillars as colorful canvases, celebrating the true spirit of Bengaluru by depicting the everyday champions who form the backbone of the city.

The initiative is not just about beautification, but about igniting a sense of pride, connection, and admiration for the unsung individuals who make the city extraordinary. By paying tribute to these individuals, the project aims to bring attention to the diverse community that gives Bengaluru its unique identity. The “Pillars of Bengaluru” project is a testament to the city’s resilience, talent, and relentless spirit, making it a must-see cultural spectacle in the heart of the city.

The Biocon Foundation, the Corporate Social Responsibility (CSR) arm of Biocon Group, has launched a public art project titled “Pillars of Bengaluru – Celebrating Everyday Champions” in Bengaluru, India. The project has transformed over 50 metro pillars along the Huskur Gate-Biocon Hebbagodi stretch into canvases that celebrate the city’s unsung heroes. The art project features intricate Channapatna art, a traditional Indian art form, which depicts individuals from various professions, including flower sellers, electricians, doctors, and IT professionals. The project aims to pay tribute to these individuals who contribute to the city’s identity.

The initiative was designed in collaboration with Srishti Manipal Institute of Art, Design, and Technology (SMI) and is part of Biocon Foundation’s efforts to enhance the commuting experience and evoke a sense of pride among citizens. The project also complements Biocon Foundation’s ₹65 crore investment in constructing the Biocon-Hebbagodi Metro Station, part of the Yellow Line connecting R.V. Road and Bommasandra.

According to Anupama Shetty, Mission Director, Biocon Foundation, the project is a visual tribute to the diverse community that gives Bengaluru its unique identity. The initiative aims to bring to life the everyday champions who form the backbone of the city, including street vendors, auto drivers, tech professionals, and artists. The project is an innovative way to showcase the city’s heritage and urban landscape, making it a unique and engaging experience for commuters.