The Malaysian government has extended its insulin supply contract with India’s Biocon Biologics for an additional six months, from April 29 to October 28. The original 36-month contract, which began in 2022 and was set to expire in April 2025, was between the Ministry of Health (MOH), Biocon’s Malaysian subsidiary Biocon Sdn Bhd, and Duopharma Marketing Sdn Bhd (DMktg). Biocon Biologics has been the Ministry of Health’s partner of choice for insulin requirements for nearly 10 years, manufacturing a range of recombinant human insulin products at its facility in Johor, Malaysia.

The company’s insulin products are distributed in Malaysia through its commercial partner DMktg. Biocon Biologics is committed to providing affordable access to life-saving insulins to people with diabetes in Malaysia and globally. The company’s facility in Malaysia not only supplies the domestic market but also exports insulin to the global market. The facility has received approvals from several regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In 2022, the company faced criticism from the Health Minister, Dzulkefly Ahmad, who blamed Biocon for failing to meet its contractual obligations, resulting in an unprecedented insulin shortage. However, the company has continued to work with the Ministry of Health to ensure a stable supply of insulin to patients in Malaysia. The extension of the contract is a testament to the company’s commitment to providing affordable and accessible insulin to those who need it. With its state-of-the-art facility in Johor, Biocon Biologics is well-positioned to meet the growing demand for insulin in Malaysia and globally.

The company’s commitment to affordable access to insulin is critical, given the growing prevalence of diabetes in Malaysia. According to the International Diabetes Federation, Malaysia has one of the highest prevalence rates of diabetes in the world, with over 3.5 million people living with the condition. Biocon Biologics’ efforts to provide affordable insulin will help to improve healthcare outcomes for these individuals and reduce the burden of diabetes on the healthcare system. Overall, the extension of the contract between the Malaysian government and Biocon Biologics is a positive development for patients with diabetes in Malaysia and reflects the company’s ongoing commitment to providing affordable and accessible healthcare solutions.

The fiscal fourth quarter earnings season is currently underway, with numerous large, mid, and small cap companies having already released their Q4 results. Major IT companies such as Tata Consultancy Services, Infosys, Wipro, and HCL Tech, as well as other prominent firms like Reliance Industries, Paytm, and SBI, have reported their Q4 performance.

Today, a range of companies including Titan Company, Larsen & Toubro, Biocon, Asian Paints, Britannia Industries, and Canara Bank are scheduled to release their Q4 results. An analysis report by Nuvama predicts that top-line growth for the fourth quarter will be 6% year-over-year (YoY) for their coverage universe, excluding oil marketing companies (OMCs), which is lower than the 8% YoY growth reported in Q3FY25.

The report notes that this will be the eighth consecutive quarter of sub-10% top-line growth. While the top line has been subdued in both FY24 and FY25, the factors contributing to this are different. In FY24, exports and low-end consumption weakened, whereas in FY25, BFSI, discretionary consumption, and capex slowed.

In terms of sector performance, Nuvama forecasts that the top line will be strong in certain sectors such as electronics manufacturing services (EMS), internet, non-banking financial companies (NBFCs), quick service restaurants (QSR), and consumer services, with growth exceeding 15% YoY. Moderate growth of 10-15% YoY is expected in sectors like durables, fast-moving consumer goods (FMCG), pharma, retail, industrials, and non-lending financials. However, sectors like IT, banks, metals, energy, paints, and cement are expected to report weak growth of less than 10% YoY.

As the earnings season continues, investors and analysts will be closely watching the performance of these companies to gauge the overall health of the economy and specific sectors. The Q4 results will provide valuable insights into the trends and growth prospects of various industries and companies, helping investors make informed decisions. With many companies still to report their Q4 numbers, the earnings season is expected to remain in focus in the coming days.

The biotech industry is booming, and numerous top companies are seeking talented professionals to join their teams. With 18 years of experience serving bio professionals and the biotech industry, Biotecnika is a trusted platform that provides updates on job opportunities in the field. Currently, several prominent companies are hiring for various roles, including clinical research, pharmacovigilance, biotechnology, and regulatory affairs.

Medpace is looking for a Clinical Research Associate to work on clinical trials, while ICON is seeking a Graduate Pharmacovigilance Associate to join their team in drug safety and clinical research. Boehringer Ingelheim, a global leader in biopharma, is hiring scientists in various fields. Charles River is offering an opportunity for freshers to start their career in immunology research as an Immunology Analyst.

Other companies, such as GenScript, Sanofi, Genentech, and Abbott, are also hiring for various roles, including biotechnologist, associate scientist, quality control associate, and clinical research associate. Schrodinger is seeking an Applications Scientist in Bioinformatics and Structural Biology, while PepsiCo is hiring a Senior Scientist in Regulatory Affairs. Gilead is looking for an Associate Scientist for Protein Therapeutics in Oxford, UK, and Oxford Biomedica is hiring a Director of Regulatory Science CMC.

These job opportunities offer a chance to work with leading companies in the biotech industry and contribute to groundbreaking research and development. Interested candidates can apply for these roles through Biotecnika’s platform, which provides a convenient and efficient way to explore job opportunities in the biotech field. With its 18 years of experience, Biotecnika has established itself as a trusted partner for bio professionals and the biotech industry, providing valuable resources and job opportunities for those looking to advance their careers in this exciting field. Whether you’re a fresher or an experienced professional, there’s a role waiting for you in the biotech industry.

Kiran Mazumdar-Shaw, the Executive Chairperson of Biocon Limited, has expressed her disappointment and concern over the current state of Bengaluru, once known as the “Garden City”. She tweeted a video showcasing the poor condition of Lal Bagh, a prominent park in the city, and lamented that Bengaluru is transforming into a “garbage city”. Mazumdar-Shaw called upon the citizens to take action and work together to restore the city to its former glory.

Her comments come after BJP MP Tejasvi Surya wrote a letter to Bengaluru Incharge Minister DK Shivakumar and BBMP Commissioner Tushar Girinath, highlighting the city’s poor infrastructure. Surya pointed out the deplorable state of roads, potholes, garbage, and broken footpaths, which he believed created a negative image of the city, especially during the recent TCS World 10K race.

Mazumdar-Shaw’s tweet sparked a sense of urgency, as she questioned what had happened to the city’s original planning and vision. She emphasized the need for citizens to take ownership and work towards regaining their city, allowing it to flourish once again. The tweet also tagged the official handles of the Bruhat Bengaluru Mahanagara Palike (BBMP) and the Bangalore Political Action Committee (BPAC), signaling a call to action for the authorities to address the issue.

The criticism from prominent figures like Mazumdar-Shaw and Surya highlights the growing concern over Bengaluru’s deteriorating infrastructure and environmental condition. The city’s rapid growth and urbanization have led to issues such as garbage management, traffic congestion, and poor public amenities. The call to action from Mazumdar-Shaw and Surya serves as a reminder that the citizens and authorities must work together to restore Bengaluru’s former charm and ensure a sustainable future for the city.

Biocon Biologics, a biopharmaceutical company, has reached a settlement and license agreement with Regeneron to commercialize its aflibercept-jbvf (Yesafili) biosimilar, an interchangeable version of Regeneron’s aflibercept, in the United States. The agreement dismisses pending patent and litigation claims in the US District Court for the Northern District of West Virginia and the US Court of Appeals for the Federal Circuit. This move clears the path for Biocon Biologics to launch Yesafili in the US, with a potential launch date of the second half of 2026 or earlier if certain circumstances arise. The terms of the agreement are confidential.

Yesafili is intended for the treatment of various eye diseases, including neovascular age-related macular degeneration, retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. The US Food and Drug Administration (FDA) approved the biosimilar in May 2024, making Biocon Biologics the first to file an interchangeable biosimilar to Eylea, Regeneron’s market-leading treatment for these conditions. This agreement marks Biocon Biologics’ strategic entry into the ophthalmology market in the US, expanding its footprint and furthering its goal to increase access to life-changing treatments.

Biocon Biologics has already secured a settlement agreement in Canada with Bayer and Regeneron for the launch of Yesafili, with a planned launch date of no later than July 1, 2025. The company’s CEO and managing director, Shreehas Tambe, commented on the settlement, stating that it paves the way for Biocon Biologics to bring a reliable and high-quality aflibercept biosimilar to patients in the US. This agreement is a significant milestone for Biocon Biologics, as it represents the company’s first launch in the US ophthalmology market and a key step in its mission to increase access to life-changing treatments.

This settlement is a testament to Biocon Biologics’ scientific expertise and its ability to navigate complex patent and litigation disputes. The company is poised to become one of the first to market a biosimilar in the US, providing patients with a more affordable and accessible treatment option. As Biocon Biologics looks to expand its reach in the US market, this agreement is a significant step forward, demonstrating the company’s commitment to delivering innovative and life-changing treatments to patients.

Siddharth Mittal, CEO of Biocon Limited, has questioned the feasibility of shifting pharmaceutical manufacturing back to the US due to higher costs. At the Carnegie Global Technology Summit, he pointed out that Indian companies cannot afford to bring back manufacturing to the US from China, where production costs are lower. According to Mittal, a drug manufactured in China costs 1.25-1.3 times its production price in India, while in the US, it would double in cost. He asked who would bear the additional expense.

Mittal also highlighted the US as a significant market for Indian pharmaceuticals, with 50% of its drugs coming from India. Many Indian companies have set up manufacturing plants in the US to tap into this market. He emphasized the importance of addressing the entire value chain, including raw materials, as India still relies on China for 70% of its starting materials.

US President Donald Trump has warned of impending tariffs on pharma imports, citing the advantage of the US being a large market. He claimed that tariffs will encourage companies to set up manufacturing plants in the US to avoid costs. However, Mittal’s concerns highlight the complexity of this issue, showcasing the logistical and financial difficulties of shifting production to the US.

Siddharth Mittal, CEO and Managing Director of Biocon Limited, expressed concerns about the feasibility of shifting pharmaceutical manufacturing from India and China to the US, due to the significant cost difference. He stated that if a drug is manufactured in China, it costs 1.25 to 1.3 times less than in India, and even more in the US, which would require someone to pay the price to bring back manufacturing to the US.

Mittal pointed out that the US is a key market for Indian pharmaceutical products, with 50% of drugs in the US coming from India, and most Indian companies having set up manufacturing plants in the US. However, the US market is price-sensitive, and Indian companies would need to be competitive to sustain operations.

India’s dependence on China for active pharmaceutical ingredients (APIs) was also highlighted, with Indian companies relying on China for 70% of their starting materials or raw materials. Mittal emphasized the need to address the entire value chain to address this issue.

The discussion came amidst warnings from US President Donald Trump about impending tariffs on pharmaceuticals, which could be implemented as a way to encourage companies to manufacture in the US. Trump stated that the tariffs would be applied to pharmaceuticals that are made in another country, including China, and that companies would be forced to open plants in the US to avoid the tariffs. Indian generic drug manufacturers play a significant role in the US healthcare system, supplying nearly 40% of the generic drugs imported into the country. The industry has experienced an 8% compound annual growth rate (CAGR) over the past decade.

Kiran Mazumdar Shaw, the founder of Biocon, recently expressed her disappointment with Bengaluru’s civic infrastructure on social media. She shared a picture of clean streets in San Cristobal Island, Ecuador, and compared it unfavorably to Bengaluru, stating, “Bengaluru, hang your head in shame.” Her post sparked a mix of reactions, with some users agreeing, citing cleaner cities in India like Mysore, Indore, and Surat.

However, others defended Shaw’s stance, pointing out that even Ecuador, a developing country, maintains better infrastructure. Some users highlighted the issue of governance failures, citing political mismanagement and linguistic concerns overshadowing civic demands. A user even compared India’s struggles with Latin America’s better infrastructure, blaming corruption as a key factor.

Shaw responded to the criticism, reaffirming that even developing countries like Ecuador manage to maintain better infrastructure. The post has sparked a national conversation about the state of India’s civic infrastructure, with some people acknowledging the country’s higher self-perception and others attributing the issues to governance failures.

The debate has also shed light on the disparities between different Indian cities and the varying levels of civic infrastructure. While some cities have made efforts to improve their infrastructure, others remain plagued by poor governance and mismanagement. The controversy has prompted many to question the priorities of the government and individuals in addressing these issues.

Ultimately, Shaw’s post has brought attention to the pressing need for improvement in India’s civic infrastructure, with many calling for more effective governance and greater public pressure to force change. The debate has also encouraged a sense of national pride and a willingness to acknowledge the issues that need to be addressed to improve the quality of life for citizens.

Biocon’s arm, Biocon Pharma, has received approval for its Norepinephrine Bitartrate Injection in the US, expanding its portfolio of complex injectables. The injection will be used to treat adults with acute hypotension and sodium nitroprusside/control of blood pressure. This approval is in addition to two other drug products that Biocon Pharma has received final US FDA approvals for: Lenalidomide Capsules and Dasatinib Tablets.

Lenalidomide Capsules are indicated for multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia of myelodysplastic syndromes (MDS) in adults. Dasatinib Tablets are approved to treat people aged 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Moreover, Biocon Pharma has received tentative approval for its abbreviated new drug application (ANDA) for Rivaroxaban Tablets USP, which will be supplied in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. Rivaroxaban is an oral anticoagulant used for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the reduction of stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation.

These regulatory approvals mark a significant milestone for Biocon Pharma, demonstrating its commitment to offering affordable, high-quality complex generics to global markets. The company’s expansion into the US market with these products reinforces its presence in the pharma industry, providing patients with access to essential medicines at an affordable price.

Biocon, an Indian generic drug manufacturer, has been hit with a patent infringement complaint in the US District of New Jersey by Impax Laboratories. The complaint is related to Biocon’s Abbreviated New Drug Application (ANDA) to sell a generic version of the Parkinson’s drug Rytary. The patents-in-suit include US Patent Nos. 8,557,283, 9,089,608, 9,463,246, 9,533,046, and 9,901,640, as well as other Rytary patents listed in the FDA’s Orange Book.

This development comes as a significant challenge for Biocon, which is already facing intense competition in the generic drug market. The company is known for its innovative approaches to drug making, including the use of biotechnology and biosimilars. However, this complaint may force Biocon to re-evaluate its strategy and potentially delay the launch of its generic version of Rytary.

The patents-in-suit are a key part of Impax’s intellectual property portfolio, and the lawsuit could have significant implications for the generic drug industry. The dispute highlights the need for companies to carefully navigate the complex web of patents and intellectual property rights when developing and marketing new medicines.

The outcome of this lawsuit could have far-reaching implications for Biocon and the broader generic drug industry. As the world’s leading source of regulatory change, MLex provides real-time updates and analysis on the latest developments in the pharmaceutical industry. With our expertise, you’ll be better equipped to anticipate and respond to changes in the regulatory landscape, ensuring your business remains ahead of the curve.

Johor has emerged as a prime location to become Asia’s largest insulin hub, with Indian biotech major Biocon’s RM1.1 billion (approximately US$274 million) investment to establish a manufacturing facility in the state.

Biocon, one of India’s largest biotechnology company, announced plans to invest in a new facility in Johor, which will produce insulin and other biotechnology products. The investment is expected to create over 1,000 high-skilled jobs during the construction phase and around 500 permanent positions after the facility is operational.

The new facility, expected to be operational by 2025, will be built on a 20-acre site in Johor’s Nusajaya region. It will feature cutting-edge production technology, including advanced fermentation facilities and isolators, to produce insulin and other essential biotechnology products. The facility will be designed to meet global regulatory standards and produce high-quality products.

Biocon’s investment in Johor is a significant boost to the state’s biotechnology sector, which has been growing rapidly in recent years. The company has chosen Johor for its strategic location, business-friendly environment, and easy access to the Southern Corridor’s BioXploit, a biotech park and an eco-system of biotech companies, research institutions, and academic centers.

The investment is expected to contribute to the development of Johor’s biotechnology industry, which has seen significant growth in recent years, driven by the state government’s efforts to promote the sector. The state has set a target to make Biotechnology a vital contributor to the state’s economy by 2025, with a projected growth rate of 10% per annum.

The investment will also provide a significant boost to the local economy, generating additional revenue and creating new job opportunities. The facility will also contribute to the state’s human capital development by providing training and skills development programs to locals, enabling them to participate in the growing biotechnology industry.

In conclusion, Johor’s emergence as Asia’s largest insulin hub will be a significant milestone in the region’s biotechnology industry. With Biocon’s RM1.1 billion investment, the state is poised to become the production hub for insulin and other biotechnology products, creating a vast array of job opportunities and contributing to the state’s economic growth. The investment is set to further solidify Johor’s position as a key player in the global biotechnology landscape.