ESN Cleer’s Post

📢Exciting News 📍 Today, Accord Biopharma, Inc. a subsidiary of Intas Pharmaceutical Ltd has gotten the acceptance of its #Biosimilar DMB-3115 which is proposed biosimilar to STELARA ® (ustekinumab) from #USFDA 📌Accord Biopharma, Inc. conducted multi-regional Phase-III clinical trail in patients with plaque psoriasis. The main focus of the study was the rate of change in the Psoriasis Area and Severity Index (PASI) to assess skin symptom improvement. 💊 STELARA®, a Janssen Biotech blockbuster, approved for psoriasis, psoriatic arthritis, Crohn's, and colitis. It raked in $13.9B in U.S. sales in 2022, ranking among top biologics. #Biosimilar #USFDA #ustekinumab #accordbiopharma #Intas https://lnkd.in/eQiVMPst

The Vizient 2024 Pharmacy Market Outlook is out now, providing insights into pharmaceutical price changes and GLP-1 agents like semaglutide and tirzepatide, which are now FDA-approved to reduce cardiovascular risks in certain adults. 

What is Product Specific Guidance (PSG)? PSGs describe FDA's current thinking and expectations to develop #genericdrugs therapeutically equivalent to specific RLDs. To facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support #anda approval, the FDA just published updated list of PSG. Here is how you find the searchable database: https://lnkd.in/dBpZN4P Also, check out this: https://lnkd.in/eFyNFV4 Sponsors and investigators of any investigational new drug (#ind)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct, including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring. Today’s batch of 32 PSGs includes:   --26 new PSGs, including 10 for new chemical entities (NCEs), and 6 revised PSGs --25 PSGs for products with no approved ANDAs (including 11 complex products)  --13 PSGs for complex products (8 new and 5 revised PSGs)  --PSGs for products used for treatment of paroxysmal nocturnal hemoglobinuria, Parkinson’s disease, Friedreich's ataxia, mantle cell lymphoma, and other conditions  --PSGs that were developed or revised based on improved scientific understanding resulting from GDUFA-funded research. These PSGs reference products used for treatment of opioid overdose, cystic fibrosis, and other conditions. #precaution, #contraindication

#Celltrion secures major supply contracts with #UniHA and #Bretagne, strengthening market leadership in France #Celltrion #Pharmaceuticals #Biosimilars #Healthcare #Innovation #France #UniHA #Bretagne #Remsima #Herzuma #Vegzelma #Omviclone #CTP43 #RASLifeScienceSolutions #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #PortfolioOptimization #MarketExpansion #PartnerIdentification

🚀 Exciting news from Celltrion! 🚀 Celltrion Inc has successfully secured bids to supply three key biopharmaceutical products #Remsima (infliximab), #Herzuma (trastuzumab), and #Vegzelma (bevacizumab) to UniHA, France's largest pharmaceutical procurement group. These biosimilars treat #autoimmunediseases, #breastandgastriccancer, #colorectalcancer, and #nonsmallcelllungcancer. #UniHA controls significant market shares: 30% infliximab, 27% bevacizumab, and 13% trastuzumab. As a result, Celltrion will be the exclusive supplier of these products until June 2027. Additionally, through the #Bretagneprocurementgroup, Celltrion will supply #Herzuma and #Vegzelma until June 2028. Celltrion’s strategy focused on strong relationships with key stakeholders, ESG achievements, and supply stability. The company's #RemsimaSC has also captured a 26% market share, contributing to a combined 76% share for the #Remsima line in France. Looking ahead, Celltrion plans to expand its participation in the French bidding market and strengthen its sales capabilities for newly approved products like #Omviclone (omalizumab) and #CT-P43 (ustekinumab). The company will aggressively participate in upcoming bids and strive for outstanding results to ensure more patients benefit from Celltrion's treatments. #Celltrion #Pharmaceuticals #Biosimilars #Healthcare #Innovation #France #UniHA #Bretagne #Remsima #Herzuma #Vegzelma #Omviclone #CTP43 #Infliximab #Trastuzumab #Bevacizumab #Omalizumab #Ustekinumab #RASLifeScienceSolutions #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #PortfolioOptimization #MarketExpansion #PartnerIdentification For Detailed News: https://lnkd.in/d94c3p4T Follow our page for more industry updates: https://lnkd.in/de5zNWmK

"The science is not enough to succeed" as this (yet another) example proves. I have been reciting my mantra to small-time life science companies who I describe as "science rich, commercially naive" for some time now. This example shows several features about drug development: 1. The huge risks involved in bringing a drug to market. 2. The fact that some therapy areas are more challenging than others for drug development. 3. The fatal flaw of focusing on science when instead they must "begin with the end in mind" (Covey: 7 Habits book) by defining the unmet need versus current standard care, how difficult, costly and risky it will be to prove the drug works with outcomes a payor will fund. 4. Not considering a payor's perspective which is never on the science, but on the impact the drug has on the burden of illness and if it can be proven to be cost-effective. Anything in neurodegenerative disease (such as Alzheimer's and dementia for example) is challenging to show efficacy. After that, the pricing becomes sensitive as recent developments in the amyloid story have proven. It seems to me that being science-rich in SMEs is akin to a Lemming philosophy where they all blindly follow each other for funding only to leap off a cliff to their death drowned in debt through commercial failure. If only.... If only they opened themselves to strong challenges about their asset from me before they drowned, they may have followed a better path towards success because with me, they would tightly define unmet need and the size of the opportunity to assess how costly and risky it would be to turn that base-metal into gold. Perhaps they should have studied alchemy instead of biochemistry?

I'm thrilled to share that my latest article has been featured in Fierce Pharma. In this piece, I explore the recent announcement of Arrowhead Pharmaceuticals phase 2 trial for its RNAi drug candidate, plozasiran, and the promising implications it holds for the dyslipidemia drug market. Check out the full article here: https://lnkd.in/ehBQBHtV #Pharma #Dyslipidemia #GlobalDataHealthcare #ArrowheadPharmaceuticals #plozasiran

In January 2024, Celltrion Inc submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...👇👇👇👇👇👇 ....for CT-P47, a biosimilar candidate of the 𝗿𝗲𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗔𝗰𝘁𝗲𝗺𝗿𝗮 (𝘁𝗼𝗰𝗶𝗹𝗶𝘇𝘂𝗺𝗮𝗯), primarily used for treating rheumatoid arthritis and systemic juvenile idiopathic arthritis. Accord Healthcare also announced that the FDA accepted its BLA for DMB-311, 𝗮 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿 𝘁𝗼 𝗦𝘁𝗲𝗹𝗮𝗿𝗮 (𝘂𝘀𝘁𝗲𝗸𝗶𝗻𝘂𝗺𝗮𝗯), which is indicated for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. However, the launch of DMB-311 faced delays due to lawsuits with the manufacturer of Stelara, Johnson & Johnson, but Accord reached a settlement allowing its launch by May 15, 2025, following FDA approval. Celltrion's BLA submission for CT-P47 was based on data from a global Phase III clinical trial evaluating its efficacy, safety, and immunogenicity compared to Actemra, specifically in patients with moderate to severe active rheumatoid arthritis. Accord's DMB-311 BLA submission was supported by results from phase III trials demonstrating its similarity to Stelara in terms of quality, safety, and efficacy, particularly in patients with plaque psoriasis. 𝗔𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹𝗹𝘆, 𝘁𝗵𝗲𝗿𝗲 𝗮𝗿𝗲 𝗼𝘁𝗵𝗲𝗿 𝘂𝘀𝘁𝗲𝗸𝗶𝗻𝘂𝗺𝗮𝗯 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 𝗶𝗻 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗯𝘆 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗹𝗶𝗸𝗲 𝗖𝗲𝗹𝗹𝘁𝗿𝗶𝗼𝗻 𝗮𝗻𝗱 Formycon AG, 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝗶𝗻𝗴 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗰𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝗼𝗻 𝗶𝗻 𝘁𝗵𝗲 𝗺𝗮𝗿𝗸𝗲𝘁 𝗳𝗼𝗿 𝘁𝗵𝗶𝘀 𝗱𝗿𝘂𝗴 𝗶𝗻 𝘁𝗵𝗲 𝗻𝗲𝗮𝗿 𝗳𝘂𝘁𝘂𝗿𝗲. See previous content: https://lnkd.in/dcN_rM9k #marketintelligence #competitiveintelligence #marketsmind #pharmaceutical #biosimilars

#China’s Center for Drug Evaluation (#CDE) has released its 2023 Annual Report on the Development of New Drug Clinical Trials. The report provided a summary and analysis of the overall landscape of clinical trials, including the total number and basic characteristics of the trials. In 2023, the total number of drug #clinicaltrials in China reached a record high of 4,300, representing a 26.1% increase📈 from 2022. Of these, new drug clinical trials accounted for 54%, while bioequivalence (BE) trials made up the remaining 46%. Notably, 91.7% of the clinical trials were applied by domestic companies. Find out more at 👇 https://lnkd.in/gQku-aGh #pharmaceutical #pharmaceuticalindustry

The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #GlobalPrecisionCancerDiagnostics #CancerCare #EarlyDetection #PersonalizedMedicine #AdvancedDiagnostics #HealthcareInnovation #OncologyResearch #PatientOutcomes #MedicalTechnology #CancerTreatment