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.

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Biocon Biologics, the biosimilar arm of Biocon, has received approval from the US FDA for Jobevne, a cancer treatment drug. This is the company’s seventh biosimilar approved in the US and its fourth oncology biosimilar. Jobevne is a biosimilar version of Bevacizumab (marketed as Avastin), a monoclonal antibody used in combination with chemotherapy to treat various types of cancer, including colorectal, lung, brain, kidney, and cervical cancers.

The approval of Jobevne expands Biocon Biologics’ oncology portfolio and adds to its existing portfolio, which includes OGIVRI (trastuzumab), FULPHILA (pegfilgrastim), and ABEVMY (another bevacizumab biosimilar approved in other markets). The US market is a significant contributor to Biocon Biologics’ revenue, accounting for 40% of its overall revenue.

The company has 20 biosimilars in its development pipeline, including insulins and monoclonal antibodies across various therapies. In addition to the US market, Biocon Biologics is seeing growth in markets like Japan and Australia through its commercial partners.

In the third quarter of 2024, the company’s biosimilars segment posted revenue of ₹2,289 crore, up 14% year-on-year on a like-for-like basis. Profits rose 5% sequentially. The oncology segment saw strong demand during the quarter, while insulin sales remained in the mid-to-high teens across all distribution channels.

The CEO and Managing Director of Biocon Biologics, Shreehas Tambe, expressed his enthusiasm for the approval of Jobevne and the company’s future plans to bring more treatment options to patients. The company is committed to working with stakeholders to develop and commercialize biosimilars that can provide affordable and high-quality treatment options to patients.

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Indian biotechnology major, Biocon Ltd, has announced plans to raise up to Rs 600 crore to fund its aggressive business growth plans.

The company plans to raise the funds through a combination of internal and external sources, including debt, equity capital, and private placements. This fundraising exercise is aimed at supporting the company’s expansion plans in domestic as well as international markets.

Biocon, led by Chairperson Kiran Mazumdar-Shaw, has been aggressively pursuing its business expansion plans, and this fund raise is a part of that strategy. The company has been making significant investments in research and development, and has been foraying into new therapeutic areas, including oncology, immunology, and rare diseases.

Biocon has a strong track record of developing and commercializing biopharmaceutical products, and has a significant presence in the global market. The company has a portfolio of over 21 molecules, including Insulin Factor 8 (IF8), insulin glargine, and pegylated granulocyte-colony stimulating factor (G-CSF).

The company’s fundraising plan is expected to be a key step in its journey towards achieving Rs 5,000 crore revenue and Rs 2,000 crore net profit by 2022-23. The company has been consistently reporting impressive growth in sales, profitability, and margins in recent years, driven by strong demand for its products.

Biocon’s strategic initiatives to boost growth include the launch of new products, expansion of manufacturing capacity, and strategic acquisitions. The company has also been investing heavily in research and development to create a pipeline of innovative products.

The company’s upcoming IPO of its arm, Syngene International, is expected to raise around Rs 400 crore. This will be a part of the overall fund-raising plan, with the remaining amount likely to be raised through an equity issue. With this fund-raising exercise, Biocon aims to solidify its position as one of the leading players in the biotechnology space, both in the domestic and global markets.

Biocon has been one of the fastest-growing companies in the Indian biotech industry, with a strong product portfolio and a robust business model. The company is expected to continue its growth trajectory in the coming years, driven by strong demand for its products and a strategic investment in research and development.

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Biocon’s CEO, Peter Bains, has resigned from his position. The news comes as a surprise, as Bains has led the company for nearly a decade, playing a significant role in its growth and success. His departure has left the company’s board of directors to deliberate on the next steps to ensure a smooth transition.

Under Bains’ leadership, Biocon has experienced significant milestones, including the launch of several new businesses, such as its entry into the global vaccine market. The company has also expanded its presence in the pharmaceutical industry, with Bains at the helm. During his tenure, Biocon has received numerous awards and recognitions, solidifying its position as a leader in the biotechnology sector.

Bains’ resignation is a significant development for Biocon, as the company looks to the future. The board of directors will now deliberate on the next steps to ensure a seamless transition and maintain the company’s momentum. The company has not yet announced a replacement for Bains, who will be leaving the company at the end of the month.

The sudden departure of Bains has raised concerns about the company’s future, with many speculating on the possible reasons behind his resignation. Some have speculated that Bains’ departure may be due to the company’s recent challenges, including competition in the biopharmaceutical industry and the ongoing pandemic. Others have suggested that Bains may be leaving to pursue other opportunities or address personal issues.

The board of directors is said to be working closely with the company’s management and key stakeholders to ensure a smooth transition and maintain the company’s momentum. The board will also need to ensure that the company’s future growth and success are not compromised, given the departure of its long-serving CEO.

As the board deliberates on the next steps, Biocon’s employees, customers, and stakeholders are left to wonder what the future holds for the company and what changes may be implemented under new leadership.

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Kiran Mazumdar-Shaw, the CEO of Biocon, took to social media to express her frustration with Bengaluru’s infrastructure. She compared the city’s streets to those in Ecuador, specifically San Cristobal Island, and criticized the poor state of urban planning. In a post on X, she shared a video of well-maintained stone roads in Ecuador and Captioned it, “Clean and well-designed streets in San Cristobal island in Ecuador. Bengaluru, hang your head in shame,” also tagging the official handle of the Special Commissioner of Bruhat Bengaluru Mahanagara Palike (BBMP).

The post sparked a lively debate on social media, with some users agreeing with Kiran’s sentiment and others offering a different perspective. Some users suggested that other cities in India, such as Mysore, Indore, Surat, and Rajkot, serve as better comparisons. However, Kiran responded, “Yes, but the point is that even Ecuador, which is a developing country, is well-maintained by the local municipality.”

Other users pointed to deeper structural issues, such as population size and social dynamics. “What’s the population of San Cristobal island and Bengaluru?” one user asked, while another added, “It’s clean because everyone tries their best to clean stuff. It’s not like privileged people only direct others to clean.”

The viral post has renewed discussions about Bengaluru’s civic issues and the state of the city’s infrastructure. Whether the authorities will take action remains to be seen. The incident highlights the need for the government to address the city’s infrastructure concerns and ensure a better quality of life for its residents.

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.

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Indian pharmaceutical firm, Thermax, and US-based bio-pharmaceutical company, USBiocon Biologics, have announced a partnership to supply insulin aspart drug substance for manufacturing in USBiocon’s plant in Petersburg, Virginia. As part of the agreement, Thermax will supply the essential component, called drug substance, which will be used by USBiocon to manufacture insulin aspart, a fast-acting human insulin used to treat diabetes.

The collaboration aims to leverage the strengths of both companies to bring high-quality, affordable, and reliable insulins to patients worldwide. Thermax, with its expertise in API (Active Pharmaceutical Ingredient) manufacturing, will provide the necessary guidance and expertise to ensure the quality and regulatory compliance of the drug substance. USBiocon, with its biologics manufacturing capabilities, will utilize the supplied drug substance to manufacture insulin aspart at its state-of-the-art facility in Petersburg, Virginia.

The partnership is expected to improve the global supply chain of insulin aspart, making it more stable and cost-effective for patients. With this agreement, Thermax and USBiocon are demonstrating their commitment to improving access to life-saving medicines, particularly in the area of diabetes management.

The supply of insulin aspart by Thermax will be a critical component of USBiocon’s manufacturing process, as it requires a precise and consistent supply of high-quality API to ensure the efficacy and safety of the final product. The partnership is expected to strengthen the companies’ position in the global pharmaceutical industry, where quality, reliability, and patient needs are top priorities.

In summary, the collaboration between Thermax and USBiocon Biologics aims to provide a reliable and high-quality supply of insulin aspart, making it accessible to patients worldwide. By leveraging each other’s strengths, the companies are working together to improve access to life-saving medicines and demonstrate their commitment to quality, patient care, and regulatory compliance.