Biosimilar

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TEVA Stock Up More than 20% in Three Months: Buy, Sell or Hold the Stock?
ZACKS· 2025-07-11 13:36
Core Insights - Teva Pharmaceutical Industries Limited's shares have increased by 21.6% over the past three months due to successful launches of biosimilars and high-value generics, strong sales growth of newer branded drugs, and cost-cutting measures [1] Branded Drug Growth - Teva is experiencing market share growth for its newest branded drugs, Austedo and Ajovy, with expectations for continued sales growth from patient expansion and international launches [3] - The company anticipates annual revenues exceeding $2.5 billion from Austedo by 2027, bolstered by the launch of Austedo XR [4] - Uzedy, launched in May 2023, is projected to generate approximately $160 million in sales by 2025 [5] - Teva's branded pipeline includes olanzapine and duvakitug, with plans for phase III trials and new drug applications in the coming years [6][7] Generics and Biosimilars Pipeline - Teva has launched several biosimilars and complex generics, including products from major pharmaceutical companies [8] - The company has a strong pipeline of biosimilars, with plans to launch seven in the U.S. and four in Europe between 2025 and 2027 [10] - Teva's U.S. generics and biosimilars business grew by 15% in 2024, driven by new product launches [11] Financial Performance and Valuation - Teva's stock has underperformed the industry, losing 25% year-to-date compared to a 9.5% decline in the industry [13][14] - The stock is trading at a price/earnings ratio of 6.30, lower than the industry average of 10.17, but above its 5-year mean of 4.11 [15] - The Zacks Consensus Estimate for earnings has seen a slight decline for 2025 but an increase for 2026 [19] Long-term Growth Prospects - Teva's newer drugs and stable generics business are contributing to a revival in top-line growth [21] - The company is optimizing operations for efficiency, aiming for an adjusted operating margin of 30% by 2027 [22] - Recent credit outlook upgrades from Fitch, Moody's, and S&P reflect improved growth prospects for Teva [23]
Alvotech Appoints Linda Jónsdóttir as Chief Financial Officer
GlobeNewswire News Room· 2025-07-10 08:40
REYKJAVIK, Iceland, July 10, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the appointment of Linda Jónsdóttir as Chief Financial Officer (CFO). Linda is a highly experienced international executive with a strong background in finance and corporate leadership. She has held senior roles across a range of industries, including banking, food technology, transportation, an ...
Johnson & Johnson's Outlook Clouded By $2 Billion Headwind
Benzinga· 2025-07-09 18:38
Group 1 - Johnson & Johnson is set to release its second-quarter earnings on July 16, with analysts estimating adjusted earnings of $2.68 per share and sales of $22.85 billion [1] - Investor focus will be on the updated 2025 guidance, the impact of tariffs and biosimilars, and the progress of the company's pipeline and recent product launches [1][3] - Bank of America Securities has updated its revenue estimates for Johnson & Johnson for 2025 and beyond ahead of the earnings release [2] Group 2 - Bank of America slightly increased its second-quarter 2025 revenue and EPS estimates by 1% due to improved foreign exchange rates, with similar modest increases projected for the later 2020s [4] - Despite the upward revisions, Bank of America maintains a Neutral rating and a price forecast of $61, considering the stock fairly valued [5] - Johnson & Johnson anticipates a $2 billion net headwind in 2025, affecting various assets while Xarelto is expected to benefit [6] Group 3 - CFO Joseph Wolk revised the estimated 2025 tariff impact down to $200 million from $400 million, with the majority expected in the second half of the year [7] - A federal court sided with the U.S. Department of Health and Human Services, rejecting Johnson & Johnson's attempt to alter its participation in the 340B Drug Pricing Program [7][8]
Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee Group in Switzerland
GlobeNewswire· 2025-07-09 08:30
Core Insights - Alvotech has announced the acquisition of Ivers-Lee Group to expand its assembly and packaging capacity for biosimilar medicines, integrating Ivers-Lee into its Technical Operations division while maintaining its status as a separate legal entity [1][2][4] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar market with a fully integrated approach and broad in-house capabilities [6] - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [6] Acquisition Details - Ivers-Lee, founded in 1947, specializes in high-quality assembly and packaging services for the pharmaceutical sector and operates in Burgdorf, Switzerland, and Lörrach, Germany [3][5] - The integration of Ivers-Lee is expected to provide Alvotech with added flexibility and capacity to meet the growing global demand for biosimilars, particularly with three new biosimilars set to launch in 2025 [2][5] Operational Capabilities - Ivers-Lee's operations include the assembly and packaging of autoinjectors, pre-filled syringes, safety devices, and vials, with a GMP license and FDA approval for its Burgdorf site [5] - The company will continue to service its existing clients and provide contract manufacturing organization (CMO) services, including blister and stick-pack activities [5]
Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee in Switzerland
Globenewswire· 2025-07-09 08:30
REYKJAVIK, Iceland and BURGDORF, Switzerland, July 09, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the expansion of its capacity for assembly and packaging with the acquisition of Ivers-Lee Group (“Ivers-Lee”), a family owned business with headquarters in Burgdorf, Switzerland specializing in providing high-quality assembly and packaging services for the pharmaceutic ...
Abbott Sees Upside on Diagnostics Growth, FreeStyle Libre Expansion
ZACKS· 2025-07-02 15:06
Key Takeaways ABT posted strong Q1 CGM sales of over $1.7B, up 21.6% y/y, on FreeStyle Libre's global momentum. Diagnostics sales rose on growing demand for routine tests, with Core Lab up 6.5% outside China. EPD organic sales grew 8% as ABT scaled up its capital-light licensing model in emerging markets.Abbott’s (ABT) diversified business portfolio appears to be well-positioned to drive continued momentum in 2025. The stock carries a Zacks Rank #2 (Buy) currently.Factors Driving ABT SharesWithin Abbott’s ...
Sandoz further asserts leadership in biosimilars, breaking ground on new Slovenia facility to expand European biosimilar hub and global market reach
Globenewswire· 2025-07-01 12:56
Core Viewpoint - Sandoz has initiated the construction of a new biosimilars production center in Brnik, Slovenia, as part of a strategic plan to capitalize on a significant market opportunity in the biosimilars sector, with an expected value of USD 222 billion over the next decade [2][3][7]. Investment and Expansion - The new production facility represents a USD 440 million investment, contributing to a total planned investment in Slovenia exceeding USD 1.1 billion by 2029 [2][7]. - This investment is part of ongoing efforts to enhance in-house manufacturing capabilities and establish a fully integrated European biosimilar hub [3][7]. Market Opportunity - The biosimilars market is projected to grow significantly due to patent expiries, with Sandoz aiming to capture a substantial share of this opportunity [3][7]. - Sandoz currently has 11 marketed biosimilars and an industry-leading pipeline of 28 molecules, positioning the company to meet increasing patient demand [4]. Strategic Importance of Slovenia - Slovenia is recognized for its skilled workforce in natural sciences and engineering, central location, cost-competitive production, and strong ties to academia and research, making it a strategic site for Sandoz's manufacturing operations [4][5]. Product Focus - The new facility will specialize in the production of injectable biosimilars, including preparation, filling, assembly, and packaging, along with quality control laboratories [4].
Alvotech and Advanz Pharma Enter into European Supply and Commercialization Agreement for Biosimilar Candidate to Cimzia® (certolizumab pegol)
Globenewswire· 2025-07-01 08:00
Core Insights - Alvotech and Advanz Pharma have entered into a supply and commercialization agreement for AVT10, a biosimilar candidate to Cimzia® (certolizumab pegol) [1][3] - This agreement is significant as AVT10 is the only biosimilar candidate referencing Cimzia® under development globally, targeting chronic rheumatic diseases [2][3] - The partnership aims to expand access to high-quality biologics for patients in Europe, with plans to launch their first biosimilars in Q4 2025 [4] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, with a pipeline that includes eight disclosed biosimilar candidates for various diseases [6] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries and a diverse product portfolio [7][8] Market Context - Cimzia® generated worldwide sales of US$2.3 billion in 2024, indicating a substantial market opportunity for Alvotech's biosimilar candidate [3] - The strategic partnership between Alvotech and Advanz Pharma is expected to enhance their biosimilars pipeline and strengthen their market position in Europe [3][4]
Biocon Biologics Receives Health Canada Approval for Yesafili™ (aflibercept); First Global Launch Scheduled for July 2025
Globenewswire· 2025-06-27 04:22
Core Viewpoint - Biocon Biologics Ltd. has received a Notice of Compliance from Health Canada for its biosimilar YESAFILI (aflibercept), marking it as the first biosimilar to EYLEA approved in Canada, with a launch scheduled for July 4, 2025 [1][3]. Company Overview - Biocon Biologics Ltd. is a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., focused on providing affordable access to high-quality biologics [1][10]. - The company has commercialized nine biosimilars and has a pipeline of 20 biosimilar assets across various therapeutic areas, including diabetology, oncology, and ophthalmology [11]. Product Details - YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several serious retinal diseases, including neovascular age-related macular degeneration and diabetic macular edema [6][4]. - The approval of YESAFILI was based on comprehensive data demonstrating its similarity to EYLEA in terms of quality, safety, and efficacy, with no clinically meaningful differences observed in a Phase 3 study [2][4]. Market Impact - The approval of YESAFILI is seen as a significant achievement for Biocon Biologics in Canada, enhancing access to advanced biologic therapies for Canadian patients and ophthalmologists [3][10]. - The launch of YESAFILI will be the company's 10th biosimilar to be commercialized globally, reflecting its commitment to expanding access to affordable biologics [3][11].
Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences
Globenewswire· 2025-06-25 12:00
Core Insights - Amneal Pharmaceuticals has announced positive topline results from a clinical trial for ADL-018, a proposed biosimilar to XOLAIR (omalizumab), which is expected to be a significant growth driver for the company in the U.S. biosimilar market valued at $3.9 billion [1][4] - The Biologics License Application (BLA) for ADL-018 is anticipated to be filed with the FDA in Q4 2025, with Amneal holding exclusive U.S. commercialization rights pending regulatory approval [3] Group 1: Clinical Trial Results - The confirmatory clinical trial for ADL-018 was a randomized, double-blind, multicenter study that evaluated its efficacy, safety, and immunogenicity compared to XOLAIR in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) [1][2] - The study met its primary and secondary endpoints, demonstrating equivalence in therapeutic outcomes and comparable safety profiles between ADL-018 and XOLAIR [2] Group 2: Market Context - Omalizumab, the reference product, is indicated for severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria, with U.S. annual sales reaching approximately $3.9 billion for the 12 months ending April 2025 [4] - The successful development of ADL-018 is part of Amneal's broader strategy to commercialize six biosimilars across eight product presentations by 2027 [3] Group 3: Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, focusing on both affordable medicines and specialty branded pharmaceuticals [5] - Kashiv BioSciences, the developer of ADL-018, is a vertically integrated biopharmaceutical company with a focus on delivering cost-effective, high-quality therapies [6][7]