DataZymes Biosimilars’ Post

Biosimilar Buzz: Top 5 Stories of the Week📰 5. A $3 billion biosimilar mis-steak? 🤯🥩 4. Celltrion & Samsung Bioepis are shaking things up with new data on biosimilars for CD & UC 🎉 3. US VA is switching to a biosimilar, Biocon Biologics partnered with Sandoz to bring 2 biosimilars to Australia🇦🇺 2. Unbranded biologics help keep competition fair and prices lower, which is good for everyone 🙌 1. Adalimumab approvals hit double digits!  https://lnkd.in/ekyjgA9Z

𝗣𝗮𝗻𝗲𝗹 𝗗𝗶𝘀𝗰𝘂𝘀𝘀𝗶𝗼𝗻: 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗙𝗼𝗿 𝗜𝗻𝗳𝗮𝗻𝘁 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗺𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Up next at 13:30, we will be welcoming the following speakers to the stage: • Nikole Kimes, Founder & CEO, Siolta Therapeutics • Ellen Turner, MD, FIDSA, Medical Officer, FDA Center for Biologics Evaluation and Research/Division of Vaccines and Related Products Applications • Dr. Amine ZORGANI, Founder, The Microbiome Mavericks This panel discusses the regulatory adjustments to infant clinical trials and the importance for the microbiome industry to include this underserved patient population. #MicrobiomeConnect #MicrobiomeConnectUSA #MicrobiomeConnectSeries

Vamorolone, a Potential Duchenne Muscular Dystrophy Therapy, Undergoes Priority Review in China Sperogenix Therapeutics has applied for approval of vamorolone for the treatment of Duchenne Muscular Dystrophy (DMD) in China. The filing has been accepted by the NMPA, and a decision is expected in the first quarter of next year. The New Drug Application is supported by comprehensive data that has already led to vamorolone's approval in the US, EU, and UK. Sperogenix holds the exclusive rights to develop and market vamorolone in China under a license agreement with Santhera. The potential approval of vamorolone in China would be a significant step forward in treating DMD. For more details please click the link! https://lnkd.in/d5JJxrpX #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

𝐂𝐞𝐥𝐥𝐭𝐫𝐢𝐨𝐧 𝐔𝐒𝐀 𝐒𝐮𝐛𝐦𝐢𝐭𝐬 𝐁𝐋𝐀 𝐟𝐨𝐫 𝐂𝐓-𝐏𝟒𝟕: 𝐀 𝐍𝐞𝐰 𝐄𝐫𝐚 𝐢𝐧 𝐑𝐡𝐞𝐮𝐦𝐚𝐭𝐨𝐢𝐝 𝐀𝐫𝐭𝐡𝐫𝐢𝐭𝐢𝐬 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 📄 Celltrion USA Celltrion USA has submitted the Biologics License Application (BLA) for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab), to the U.S. FDA. 💊 CT-P47, containing tocilizumab, aims to provide a more accessible treatment option for rheumatoid arthritis. The submission is based on positive Phase III trial results, evaluating efficacy, safety, and more. 👥 Thomas Nusbickel Tom Nusbickel, Chief Commercial Officer at Celltrion USA, emphasizes the importance of this step in offering patients a diverse product lineup in the autoimmune disease market. 📆 Stay tuned as Celltrion actively cooperates with the FDA for a potential new treatment option for rheumatoid arthritis. #HealthcareInnovation #Biotech #FDASubmission #RheumatoidArthritis #BioPharma #MedicalAdvancements #CTP47 #ACTEMRA #CelltrionUSA #ClinicalTrials

Unlocking Access: The Power of Biosimilars in Healthcare 💡🔬 Multiple sclerosis (MS) is a chronic autoimmune disease that affects the central nervous system. It occurs when the immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. #biosimilars #healthcareinnovations

The comparability strategy for a post-approval production cell line change of a bevacizumab biosimilar (IBI305 from Innovent) is presented. Cell line changes are considered to have a relatively high potential risk to product safety and efficacy. Demonstrating the comparability for post-approval production cell line change poses a big challenge. Therefore, such changes are often done before pivotal studies during clinical trials. Altruist Biologics' recent case study demonstrates a three-way analytical and non-clinical comparability study strategy. Learn more about the successful outcome of this post-approval cell line change and its alignment with Altruist’s CDMO mission today. https://hubs.ly/Q02s0s410

Our latest review article, "PATHOLOGICAL SIGNALING PATHWAYS AND THERAPEUTIC STRATEGIES FOR CARDIAC FIBROSIS," has now been published in the esteemed *World Journal of Pharmacy and Pharmaceutical Sciences*. We explore cardiac fibrosis, its signaling pathways, and cutting-edge anti-fibrotic therapies. By understanding these pathways, we aim to improve patient outcomes. 🔗 Read the full article here: [Link](https://lnkd.in/debPACsk) Kudos to the entire research team! Let's make a difference in cardiac health together. 💪🫀 #CardiacFibrosis #ResearchPublication #MedicalAdvancements #HeartHealth #ScientificDiscovery

📣 We have news to share! Cybin Inc has entered into an agreement to acquire Small Pharma, creating an international clinical-stage leader in novel psychedelic therapeutics. Learn more at a joint Cybin and Small Pharma conference call today, August 28 2023 at 11.30am ET. Details on how to join are in the full press release - link below 👇 This combination means: ✔ Two proprietary, advanced clinical programs in development with demonstrated safety and efficacy ✔ The industry’s largest, most advanced, well-protected deuterated DMT program  ✔ The largest intellectual property portfolio in the psychedelic drug development sector with 28 patents granted and 158 patents pending “This marks the beginning of an exciting new chapter for Small Pharma,” our CEO George Tziras commented. “We look forward to combining the strengths of our teams to create a category leader in novel psychedelic-based therapeutics and bring innovative mental health treatments to patients around the world.” Full press here: https://lnkd.in/e4t58gJP

Structure Therapeutics (GPCR) Steps Up Games in Weight-Loss Market (June 4, 11:00 UTC+8) GPCR reported significant advances in its new Phase 2a study of weight-loss drug GSBR-1290. The drug has clinically demonstrated 6.2% weight-loss efficiency in 12 weeks. Ongoing studies will focus on reducing side effects including nausea and vomiting. Notes: Eli Lilly (LLY)’s weight-loss drug ZepBound topped $517M in sales last quarter. Another notable competitor from the scene is Novo Nordisk (NVO) who recently launched multiple legal actions against counterfeit semaglutide, a key ingredient of its in-house weight-loss drug, Wegovy.

Since the approval of three ADCs (Polivy, Padcev, and Enhertu) within 2019, this success further validated this type of drugs. It lighted the ADC industry and has attracted an increasing number of companies to develop a variety of ADC drugs. As a leading global CRDMO company, WuXi XDC is committed to enhancing our platform continuously, propelling, and transforming the development of the ADC industry, aiming to empowering our clients to accelerate development of novel ADCs that benefit patients worldwide.   On February 28, Dr. Marie Zhu, CTO of WuXi XDC delivered a speech entitled as “Superior Payload-linker and Conjugation Technologies for Novel and Better ADCs” at the 2024 Antibody-China Conference in Shanghai. Marie laid out our company’s technology platform development strategy and gave highlights on our integrated discovery service where we offer options of novel payload-linker and conjugation technologies, the enriched toolbox partnering with IntoCell Inc, Multitude Therapeutics, HySlink Therapeutics, and Syntabio to enable our clients to accelerate selection of ADC lead molecules and develop better ADCs. #adc #adcs #antibodydrugconjugates #antibodydrugconjugate #CDMO #CRDMO #payloads #linkers #payload #linker