Latest news with #biosimilars
Yahoo
13 hours ago
- Business
- Yahoo
Dr. Reddy's Laboratories (RDY) and Alvotech Enter Into a Collaboration and License Agreement
Dr. Reddy's Laboratories Limited (NYSE:RDY) is one of the Best Indian Stocks to Buy for Next 5 Years. Dr. Reddy's Laboratories Limited (NYSE:RDY) and Alvotech announced that they have entered into a collaboration and license agreement to co-develop, manufacture, and commercialize a biosimilar candidate to Keytruda® (pembrolizumab) for the global markets. Just to provide a brief overview, Keytruda® (pembrolizumab) is indicated for treating numerous cancer types. A worker at a biopharmaceutical facility packaging an active pharmaceutical ingredient. This collaboration combines Dr. Reddy's Laboratories Limited (NYSE:RDY)'s and Alvotech's proven capabilities in biosimilars, which will help speed up the development process and extend the global reach for the biosimilar candidate. Dr. Reddy's Laboratories Limited (NYSE:RDY)'s top management believes that the collaboration reflects its ability to develop and manufacture high-quality and affordable treatment options. Furthermore, oncology remains a top focus therapy area, and this collaboration is expected to further enhance its capabilities in oncology, with pembrolizumab representing one of the most critical therapies in immuno-oncology. Dr. Reddy's Laboratories Limited (NYSE:RDY) reported its financial results for the quarter and year ended March 31, 2025. It saw double-digit growth across its businesses, thanks to the successful product launches, higher revenues from key products in the US, and the integration of the acquired NRT business. Its FY 2025 consolidated revenues came in at INR325.5 billion, reflecting YoY growth of 17%. Its underlying revenue growth, excluding NRT business, stood at 12% YoY. Headquartered in Hyderabad, India, Dr. Reddy's Laboratories Limited (NYSE:RDY) operates as an integrated pharmaceutical company. While we acknowledge the potential of RDY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
2 days ago
- Business
- Yahoo
Organon & Co. (OGN) Restructures, Expands in Women's Health and Biosimilars
We recently published Organon & Co stands tenth on our list and has expanded in women's health and biosimilars. Organon & Co. (NYSE:OGN), a global healthcare company specializing in women's health, biosimilars, and established brands, underwent major changes in 2025. On May 1, the company slashed its quarterly dividend from $0.28 to $0.02 per share (annualized from $1.12 to $0.08) to prioritize debt reduction following its $1.2 billion acquisition of Dermavant in late 2024. This shift led to a 27% drop in stock price and a shareholder lawsuit alleging securities fraud due to prior reassurances about maintaining the dividend. In April, Organon & Co. (NYSE:OGN) laid off 93 employees at its Jersey City headquarters, part of an ongoing global restructuring that began in 2023 and impacted around 5% of the workforce in early 2025. The restructuring responds partly to the loss of exclusivity for Atozet, the company's second-largest product, which saw sales drop 9% in 2024, with continued decline expected. A robotic arm picking up a product assembly line, displaying the company's consumer healthcare and wellness offerings. That same month, the corporation acquired U.S. commercial rights to TOFIDENCE, a biosimilar to ACTEMRA (tocilizumab), from Biogen, expanding its immunology biosimilars portfolio. Organon & Co. (NYSE:OGN) will pay upfront fees, royalties, and milestone payments, while Bio-Thera Solutions retains U.S. manufacturing rights. TOFIDENCE enters a competitive space alongside Celltrion's Avtozma and Fresenius Kabi's Tyenne. On June 12, the business partnered with Evvy to increase access to XACIATO (clindamycin phosphate) vaginal gel 2%, reaffirming its women's health focus. Its flagship product, Nexplanon, posted 14% growth last quarter. In leadership news, Ramona A. Sequeira, President at Takeda, will join the company's Board on July 1, serving on the Talent Committee, as the company continues its strategic transformation. While we acknowledge the potential of OGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
17-07-2025
- Business
- Globe and Mail
Biosimilars Market worth US$72.29 billion by 2035 with 7.5% CAGR
The biosimilars market is estimated to reach USD 66.9 billion by 2028 from USD 29.4 billion in 2023, at a CAGR of 17.8% during the forecast period. The growth of this market is mainly driven by rising demand for biosimilars in developed and developing countries, favorable reimbursement policies and launch of novel biosimilars in the market. The global Biosimilars Market, valued at US$32.75 billion in 2024 stood at US$35.04 billion in 2025 and is projected to advance at a resilient CAGR of 7.5% from 2025 to 2035, culminating in a forecasted valuation of US$72.29 billion by the end of the period. This growth is driven by several key factors, including a rising number of regulatory approvals and product launches, the patent expiries of major biologics, and the increasing prevalence of chronic diseases that require effective and affordable treatment options. Furthermore, cost containment pressures in global healthcare systems and a surge in R&D collaborations among biopharma companies have significantly accelerated biosimilar development and commercialization. Notably, the first biosimilar version of the blockbuster GLP-1 agonist Semaglutide is projected to launch in China by 2026, and it is anticipated to contribute to approximately 25% of the global biosimilars market share by 2035, underscoring its transformative impact on the market landscape. However, the intricacies involved in the manufacturing processes of biosimilars may present challenges that could impede market expansion throughout the forecast period. Browse in-depth TOC on " Biosimilars Market" 420 - Tables 58 - Figures 391 - Pages By indication, the escalating global burden of cancer, coupled with the high costs associated with biologic therapies, has positioned oncology as the leading segment in the biosimilars market. These biologic medications offer a cost-effective alternative to reference products, thereby improving patient access to crucial treatments. The heightened investment in R&D within oncology has established biosimilars as a strategic option for healthcare systems aiming to enhance treatment affordability. The primary biosimilars utilized for oncological treatments include trastuzumab, bevacizumab, rituximab, filgrastim, epoetin alfa, and denosumab. Ongoing regulatory approvals continue to expand this market segment, while sustained research initiatives and collaborative endeavors are poised to augment market development further. By Drug Class, Infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, ustekinumab, risankizumab, and other monoclonal antibodies are biologic therapeutics for managing autoimmune diseases, malignancies, chronic conditions, and infectious diseases. These agents are engineered through recombinant DNA (rDNA) technology, enabling them to selectively target specific antigens or cellular receptors, which enhances their therapeutic efficacy and specificity. The introduction of biosimilars for these established mAbs has the potential to significantly reduce healthcare expenditures while improving patient access to vital therapies. Moreover, with the patent expirations of several prominent mAbs, the subsequent surge in market competition is expected to drive down prices and generate increased pharmaceutical interest in mAb development. Given their affordability and versatility across oncology and autoimmune therapy, mAb biosimilars are poised to play a pivotal role in shaping the future landscape of therapeutic options. By geography, the European market has emerged as the leading contributor to the biosimilar sector, driven by pro-biosimilar governmental policies, heightened investments in research and development, and an increasing disease burden. Key suppliers in this arena include France, Italy, Spain, Germany, and the UK. The European Medicines Agency (EMA) has approved 132 biosimilars across various therapeutic classes, enhancing patient access, lowering treatment costs, and expediting market entry. This approval encompasses a range of biologics, including insulin, TNF inhibitors, VEGF inhibitors, and monoclonal antibodies. Notably, in February 2025, the European Commission approved YESINTEK, Biocon Biologics' biosimilar of ustekinumab, underscoring Europe's commitment to improving access to biologic therapies and reinforcing its leadership position in the global biosimilars landscape. Key players in the biosimilars market include Sandoz Group AG (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion, Inc. (South Korea), Biocon (India), Dr. Reddy's Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), and STADA Arzneimittel AG (Germany). Biocon (India): In March 2025, Biocon entered into a strategic collaboration with Civica, Inc. to manufacture and market insulin Aspart in the US jointly. As per the agreement, Biocon will provide the drug substance for insulin Aspart, while Civica will handle the downstream processes, including drug development, clinical trials, and the production of the final drug product. This partnership aims to bring biosimilars to the US market, leveraging both companies' strengths in biopharmaceutical development and commercialization. In February 2025, Dr. Reddy's collaborated with Shanghai Henlius Biotech (China) to commercialize HLX15 (daratumumab), a biosimilar candidate to Darzalex and Darzalex Faspro, in the US and Europe. Sandoz Group AG (Switzerland) Sandoz Group AG, a prominent player in the biosimilars sector, has strategically concentrated on launching first-to-market products for high-value biologics, exemplified by its offerings Pyzchiva (ustekinumab) and Tyruko (natalizumab). In addition to its commitment to innovative product launches, Sandoz has enhanced its capabilities in manufacturing, technology, and production capacity. A key development in this arena occurred in May 2023, when Sandoz partnered with Just-Evotec Biologics, a CDMO specializing in continuous biomanufacturing; this collaboration develops and manufactures multiple biosimilars, thereby advancing Sandoz's pipeline to a robust total of 24 assets. For more information, Inquire Now!
Yahoo
16-07-2025
- Business
- Yahoo
Alvotech (ALVO) Announces Acquisition of Ivers-Lee Group
Alvotech (NASDAQ:ALVO) is one of the best oversold NASDAQ stocks to buy now. On July 9, Alvotech (NASDAQ:ALVO) announced that it is expanding its capacity for assembly and packaging by acquiring Ivers-Lee Group, a family-owned Swiss company that specializes in high-quality pharmaceutical assembly and packaging services. A scientist in a laboratory working on drug research. Although Ivers-Lee will continue existing as a separate legal entity, its operations will be integrated into Alvotech's (NASDAQ:ALVO) Technical Operations division. The acquisition would, therefore, support Alvotech's (NASDAQ:ALVO) ambitious growth plans, increasing its flexibility and capacity to meet the rising global demand for biosimilars. Robert Wessman, founder, chairman, and CEO of Alvotech (NASDAQ:ALVO), stated that the company is preparing for the launch of three new biosimilars in 2025, along with sales growth in global markets, and that the acquisition would support these plans. Alvotech (NASDAQ:ALVO) is a biotechnology company that develops and manufactures biosimilar medicines. Headquartered in Luxembourg, the company operates in the following geographical segments: Europe, North America, Asia, and Other. While we acknowledge the potential of ALVO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error al recuperar los datos Inicia sesión para acceder a tu cartera de valores Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos
Yahoo
14-07-2025
- Business
- Yahoo
Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines
Despite contributing €56 billion in cost savings across Europe, biosimilars face inadequate and misaligned policies that discourage continued investment in biosimilar development, resulting in 'biosimilar void' Whitepaper proposes multiple policy recommendations to ensure the value of biosimilars is fairly reflected in access and pricing decisions, enabling the biosimilar industry to remain sustainable and continue providing high-quality medicines at affordable prices INCHEON, Korea, July 14, 2025--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today published a whitepaper titled 'Solving the Biosimilar Void in Europe' that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. Biosimilars have played a significant role in alleviating the financial burden on the European healthcare system, having delivered €56 billion in cumulative cost savings across Europe over the past 11 years (2013-2024).1 However, the current policy environment in Europe, particularly the post-launch pathways, is misaligned to incentivize biosimilar competition. With post-marketing challenges, on top of high development costs, many biologics will not face biosimilar competition at the point of loss of exclusivity (LoE) within the next decade. The whitepaper proposes several measures to improve current practices that hinder healthy market competition and timely access to biosimilar medicines: Health Technology Assessment (HTA) needs to be tailored for biosimilars: With its origin in innovative medicine, HTA is a multidisciplinary process that evaluates the medical, social, economic, and ethical implications of health technologies. Some countries often have oversimplified HTA requirements for biosimilars, where reimbursement decisions are solely based on price comparisons and do not take into account biosimilars' additional benefits or where the reference biologic is not reimbursed. In many cases, HTA is relevant, but with limited guidance to properly assess the biosimilar's value. HTA can be more streamlined and tailored to speed up the entry of biosimilars to the market. In some countries, pricing and reimbursement (P&R) policies focus on achieving the lowest possible prices through mechanisms such as price linkage and reference pricing, thereby accelerating price erosion: Out of 28 European countries, 12 countries use external reference pricing methods and 17 countries mandate arbitrary discounts on biosimilar prices at an average of 28% below reference product.2 Already set at significantly lower levels, biosimilar prices are driven further downward as competition begins, often leading to price erosion that drives players out of the market. Instead of arbitrary price-controls, free pricing will allow price discounts to be achieved naturally through free competition. Tenders often favor a single-winner system and tend to overlook broader qualitative factors such as supply stability and quality assurance: National, regional, and local tenders should support supply diversification and fair competition through multi-winner systems, with greater transparency in communication and more periodic tender reopenings so that late entrants are also given opportunities to participate. Security and stability of supply should be given higher priority in tenders to enhance demand predictability and incentivize manufacturers to secure more robust supply chains. Biosimilar uptake cannot be achieved without the support of physicians and pharmacists who prescribe and dispense these medicines: Incentives extended to healthcare professionals to encourage the prescribing and dispensing of biosimilars vary significantly across European countries. In some countries, prescriber incentives are misaligned, discouraging the use of biosimilar medicines. Incentive programs should be based on shared decision-making between physicians and patients, rather than automatic switching. Gainsharing can be introduced to stimulate biosimilar uptake while preserving competition and autonomy. Education programs for physicians, pharmacists, and patients should be continued to support wider use of biosimilars. "Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline," said Adam Levysohn, Vice President and Head of Commercial Strategy Europe, at Samsung Bioepis. "It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience." Samsung Bioepis is a biopharmaceutical company that develops and manufactures high-quality biosimilars to accelerate patient access to biologic medicines. As a world leader in biosimilars, Samsung Bioepis has a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Of the 11 biosimilars approved worldwide, eight products are available across Europe. To access the report Solving the Biosimilar Void in Europe, please visit HERE. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: and follow us on social media – LinkedIn, X. ____________________ 1 IQVIA. The Impact of Biosimilar Competition in Europe. January 2025. Available at: 2 Medicines for Europe. The 2023 Market Review – European Biosimilar Medicine Markets – Policy Overview. September 2023. Available at: View source version on Contacts MEDIA CONTACT Anna Nayun Kim, Yoon Kim, Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
