Sandoz Group AG
🇨ðŸ‡Switzerland
- Country
- 🇨ðŸ‡Switzerland
- Ownership
- Public
- Established
- 1986-01-01
- Employees
- 20K
- Market Cap
- $19B
- Website
- http://www.sandoz.com
First Patient Dosed in Phase 2 OASIS Trial of TNX-102 SL for Acute Stress Reaction Following Trauma
• Tonix Pharmaceuticals has initiated dosing in the Phase 2 OASIS trial evaluating TNX-102 SL for reducing acute stress reaction severity and acute stress disorder frequency following traumatic events.
• The investigator-initiated study, sponsored by UNC and supported by a $3 million DoD grant, will enroll approximately 180 motor vehicle collision survivors through emergency departments across the U.S.
• TNX-102 SL, a sublingual cyclobenzaprine formulation that has shown promise in improving sleep quality in PTSD patients, addresses a significant unmet need as no medications currently exist for immediate post-trauma treatment.
Pharma Leadership Shuffle: Key Executive Moves in Early 2025 Reshape Industry Landscape
• The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda.
• Former FDA CDER Director Patricia Cavazzoni's move to Pfizer as Chief Medical Officer has sparked "revolving door" criticisms, highlighting ongoing concerns about regulatory-industry transitions.
• Several biotechnology firms have strengthened their executive teams with specialized expertise in clinical development, particularly in areas like stroke treatment, antibody-drug conjugates, and neuropsychiatric therapies.
Henlius and Sandoz Partner on Ipilimumab Biosimilar in $301 Million Deal to Expand Global Access
• Henlius has granted Sandoz exclusive commercialization rights for its ipilimumab biosimilar HLX13 across major markets including North America, Europe, Japan, and Australia.
• The agreement includes a $31 million upfront payment to Henlius, with potential milestone payments bringing the total deal value to $301 million.
• This strategic partnership aims to accelerate patient access to an important immuno-oncology therapy, leveraging Sandoz's global leadership in biosimilars and Henlius's development and manufacturing capabilities.
Sandoz Files Antitrust Lawsuit Against Amgen to Unlock Access to Etanercept Biosimilar in US Market
• Sandoz has initiated antitrust litigation against Amgen, alleging the company unlawfully blocked competition for its blockbuster drug Enbrel® (etanercept) by manipulating patent rights to maintain market dominance.
• Despite receiving FDA approval in 2016, Sandoz's biosimilar Erelzi® remains unavailable to approximately 7.5 million Americans with inflammatory conditions who could benefit from more affordable treatment options.
• The lawsuit seeks an injunction to clear the path for Erelzi® launch and damages that could be tripled under applicable laws, challenging Amgen's $3.3 billion US revenue stream from Enbrel® in 2024.
2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars
• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition.
• Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition.
• The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.
EMA Proposes Streamlined Approval Process for Biosimilars to Enhance Patient Access
• The European Medicines Agency (EMA) has released a draft reflection paper outlining a simplified approval pathway for biosimilars that could reduce clinical data requirements while maintaining safety standards.
• The proposed approach focuses on structural and functional comparability along with pharmacokinetic data, potentially eliminating the need for extensive clinical efficacy studies in biosimilar development.
• If implemented in 2026 after the consultation period ends in September 2025, the streamlined process aims to increase market competition and improve patient access to critical biological treatments across the EU.
Avecho and Sandoz Partner in Landmark $19M Deal to Develop OTC CBD Insomnia Treatment
• Avecho Biotechnology and Sandoz have signed a 10-year exclusive licensing agreement worth up to US$19 million to develop and commercialize a CBD-based insomnia treatment for the Australian market.
• The agreement includes a US$3 million upfront payment and potential milestone payments of US$16 million, plus tiered royalties of 14-19% on net sales, targeting Australia's estimated US$125 million OTC CBD market.
• The pharmaceutical CBD capsule aims to become Australia's first TGA-registered over-the-counter CBD medicine for insomnia, addressing a significant medical need affecting 9.5 million Australians.
Four New Humira Biosimilars Launch in US Market with Steep Discounts up to 85%
• Multiple pharmaceutical companies including Organon, Samsung Bioepis, Sandoz, and Boehringer Ingelheim launched Humira biosimilars in July 2023, offering significant price reductions compared to the original drug.
• Boehringer Ingelheim's Cyltezo becomes the first FDA-approved interchangeable biosimilar to Humira, allowing direct substitution without requiring prescription changes.
• The biosimilar launches come as AbbVie's Humira faces declining sales, with international revenues dropping 25% in Q1 2023 following the drug's $200 billion lifetime sales.
FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups
• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability.
• Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk.
• The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.
Sandoz Launches Pyzchiva, A New Ustekinumab Biosimilar, Expanding Access to Critical Autoimmune Treatment in US
• Sandoz has launched Pyzchiva (ustekinumab-ttwe) in the US market, offering a more affordable treatment option for approximately 12 million patients with chronic inflammatory conditions.
• The biosimilar is approved for multiple indications including moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in both adult and pediatric patients.
• Pyzchiva offers enhanced features including extended stability with re-refrigeration capability and a full suite of dosing options, with interchangeability status expected in first half of 2025.
FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara
• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions.
• Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications.
• These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.
Novartis' Kisqali Receives EC Approval for Early Breast Cancer Treatment
• The European Commission (EC) has approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment of HR+/HER2- early breast cancer.
• The approval is based on the Phase III NATALEE trial, demonstrating a 25.1% reduction in the risk of disease recurrence compared to endocrine therapy alone.
• Kisqali is now approved for a broader population of early breast cancer patients in Europe, including those with node-negative disease at high risk of recurrence.
• The decision follows positive recommendations and aligns with recent FDA approvals and NCCN guidelines, reinforcing Kisqali's role in early breast cancer treatment.
Leqembi's EU Approval Faces Further Delay as EMA Re-evaluates Safety Data
• The European Commission has requested the EMA to re-examine Leqembi's safety data, potentially delaying its EU approval beyond the expected timeframe.
• The CHMP will assess recent safety data to determine if an update to its positive opinion is needed, particularly regarding risk minimization measures.
• Eisai and Biogen believe existing data support Leqembi's safety profile, reinforced by clinical use in the US and other approved regions.
• Leqembi is already approved in the US, Japan, China and other countries, with a new once-monthly intravenous maintenance dose approved in the US.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
US Biosimilar Market Set for $100 Billion Cost Reduction as Adoption Accelerates
• The US biosimilar market has shown significant growth with 20 approved products, projected to reduce drug costs by $100 billion over the next five years through increased competition and adoption.
• Recent oncology biosimilars in bevacizumab, trastuzumab, and rituximab markets are achieving record market share, expected to reach 60% combined volume share within two years of launch.
• Regulatory changes have expanded biosimilar categories to include 90 new molecules, with insulin biosimilars poised to enter the market and potentially transform diabetes care costs.
Evolution of Pharmaceutical Industry: From Apothecaries to Modern Drug Development Giants
• The pharmaceutical industry transformed from traditional apothecaries in the 19th century to scientific enterprises, with companies like Merck and Pfizer pioneering industrial medicine production.
• Major breakthroughs including insulin treatment and penicillin development in the early 20th century marked the beginning of modern pharmaceutical research and mass production.
• Recent innovations in immunotherapy, gene therapy, and COVID-19 vaccines showcase the industry's advancement, while challenges remain in antibiotic development and drug pricing.
US Biosimilar Market Reaches Critical Milestone: Key Learnings from 5 Years of Growth
• The US biosimilar market has evolved significantly since Sandoz's Zarxio launch five years ago, with six major biosimilar launches occurring in recent months and potential cost savings of $54 billion through 2026.
• Physician confidence remains a significant barrier to biosimilar adoption, with 74% of surveyed physicians citing it as a major challenge, highlighting the critical need for enhanced educational initiatives.
• Strategic planning, comprehensive provider education, and continued advocacy efforts have emerged as crucial factors for successful biosimilar market penetration and sustainability.
FDA Approves Sandoz's Erelzi as First Enbrel Biosimilar in US
• Sandoz's Erelzi (etanercept-szzs) has received FDA approval as the first biosimilar to Amgen's Enbrel, covering all indications of the reference product for inflammatory diseases.
• The approval marks a significant milestone in the US biosimilars landscape, potentially impacting the $5 billion annual US market for Enbrel.
• The biosimilar approval aligns with healthcare cost reduction goals, with IMS Health projecting potential savings of up to $110 billion by 2020 across the US and five largest EU countries.
FDA Approves Record 45 New Drugs in 2015, Led by Breakthrough Cancer Immunotherapy Opdivo
• The FDA approved 45 new drugs in 2015, marking a significant rise in R&D productivity, with Bristol-Myers Squibb's immunotherapy Opdivo leading the pack with five new indications for various cancers.
• Novel treatments like Vertex's Orkambi for cystic fibrosis and Novartis's Entresto for heart failure demonstrated remarkable clinical innovation, though pricing concerns remained central to industry discussions.
• The year saw major developments in drug pricing debates, with the emergence of ICER as an independent US cost-effectiveness watchdog and increased scrutiny of pharmaceutical pricing practices.
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