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EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Reports Prescriber Opinions on Biosimilars in Immunology Data Insights The gold standard of business intelligence. Find out more Sign up for our daily news round-up!
A Further Examination of Pharmacy Benefit Managers Nicholas Saraceno, Editor March 29th 2024 Podcast Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drugprice transparency.
EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drugprices? Market growth will be led by the US, which accounted for over 70% of HS sales in 2024 due to a larger diagnosed population, broader biologic access, and premium pricing.
AI in value-based pricing and RWE generation AI has the potential to transform value-based pricing (VBP) by leveraging machine learning for dynamic pricing models that adjust drugprices based on real-world patient outcomes.
This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs.
According to Trump, patients could see cost reductions of 30% to 80%, but experts question the feasibility and practicality of implementing such a policy within the complex United States drugpricing and supply system. Kennedy Jr, is permitted to develop a new rule that ties American drugprices to those of other nations.
In some cases, these events might be entirely unpredictable, forcing them to adapt product strategies with little to no advanced preparation. Disruptions such as pandemics and natural disasters pose a major challenge for hospitals. Luckily, intelligent medication management software can play a crucial role in responding to disruptions.
Go deeper with GlobalData Reports Chemotherapy in Pharmaceuticals: Platinum-based cancer drug composi. Reports Biosimilars in Immunology Data Insights The gold standard of business intelligence. Reports Biosimilars in Immunology Data Insights The gold standard of business intelligence.
Final thoughts Budget cuts may be coming, driven by drugpricing changes or economic pressures. Build in the ability to track key metrics such as time to therapy, abandonment rates, and financial impact of hub performance. Be ready to defend your hub by showing how it directly improves prescription lift, fills, and patient adherence.
Trikafta, known under the brand name Kaftrio in Europe, is the best-selling cystic fibrosis drug in the world, generating revenue of $11.02bn in 2024. Kaftrio loses patient protection in 2037, at which point biosimilars are set to enter the market. Historically, this erodes the market dominance held by the branded drug.
Biosimilars and generics flood the market upon patent loss, which exerts pricing pressure on the branded product. There has been a push by the Trump administration to increase biosimilar and generic drug use in the US. Biosimilars and generics can be as much as 80% cheaper than branded alternatives.
Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription DrugPricing to American Patients,” with the objective of lowering drugprices, namely on branded drug products, for American consumers. How Does DrugPricing in the US Compare With Other Countries?
Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest E. The partnership will enhance the availability of the affordable biosimilar on a global scale. The biosimilar is a recombinant humanised antibody Fab’ fragment targeting TNFα, conjugated to a 40kDa polyethylene glycol.
Gaulkins presentation, Product Price Increases: A SPTR Practical Walkthrough , will provide an interactive case study outlining the hypothetical enforcement, appeal, and settlement scenarios that may apply to qualifying drugprice increases. FDA Law Blog readers are offered a discount of 10% off the registration price.
The Trump Administration has revived the most-favored nation (MFN) drugpricing model as a seven-year test, which would tie US drugprices to the lowest prices paid by certain OECD countries—an approach previously blocked by courts. Concerns over price controls. What is MFN model pricing?
Biocon Biologics’ Denosumab biosimilars, Vevzuo and Evfraxy, have received marketing authorisation in the European Union (EU). The drug addresses bone loss due to hormone ablation therapy in men with prostate cancer and is used in long-term systemic glucocorticoid therapy in adults.
Go deeper with GlobalData Reports LOA and PTSR Model - Bevacizumab Biosimilar in Endometrial Cancer Reports LOA and PTSR Model - Iparomlimab + Tuvonralimab in Nasopharyngeal C. How will RFK Jr’s American dream for vaccines play out? Data Insights The gold standard of business intelligence. Find out more Sign up for our daily news round-up!
How Recent Executive Orders Impact the DrugPricing Landscape Nicholas Saraceno, Editor May 30th 2025 Podcast Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drugpricing and market access.
In a year of major change and outstanding questions, growing scrutiny on patent protection and drugpricing, and uncertainty around global price control measures and the Inflation Reduction Act, understanding the implications of new leadership and emerging mandates is critical. FDA Law Blog is a conference media partner.
Compounded GLP-1RAs have completely disrupted pricing frameworks for Wegovy and Mounjaro, what happens now? Robert Barrie June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The list price for a month’s supply of 2.4mg Wegovy – the drug’s highest does – is $1,350 in the US, whereas the same dose in the UK costs £175.80
You can access the conference brochure and sign up for the event here. Raimondo Exploring the On-Sale Bar and Applicability of Prior Art Orange Book Delisting Attempts Navigating ODP and Patent Family Dynamics Hyman, Phelps & McNamara, P.C.s FDA Law Blog is a conference media partner. The discount code is: D10-999-FDA25.
How Recent Executive Orders Impact the DrugPricing Landscape Nicholas Saraceno, Editor May 30th 2025 Podcast Alice Valder Curran outlines the steps manufacturers should take to better prepare for upcoming executive actions on drugpricing and market access. JAMA Netw Open. 2025;8(6):e2513394.
Editor’s note: A livestream of the event will be embedded below at 1 p.m. Now that biosimilar versions of Humira are starting to arrive, what happens next? Will this finally prove the case that biosimilars can deliver on big health care savings? Read the rest…
ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUGPRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.
6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.
REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the poster here.
REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. View the poster here.
This page describes the event and explains how to purchase a registration to the live event. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia. This event can be both a capstone of your annual learning and a touchpoint for the future. d/b/a Drug Channels Institute.
The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.
ET This page describes the event and explains how to purchase a registration. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. Anyone who registered for the entire series will receive an email with a link to access the June event. Friday, September 24, 2021, from 12:00 p.m. to 1:30 p.m.
The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.
Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s latest live video webinar: Drug Channel Implications of the Inflation Reduction Act This event will be broadcast live on Friday, April 5, 2024, from 12:00 p.m. to 1:30 p.m.
It’s time for our most popular event of the year! Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. Dr. Adam J. to 1:30 p.m.
prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”
ET This page describes the event and explains how to purchase a registration. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. Anyone who registered for the entire series should have received an email with a link to access the December event. Broadcast live on December 17, 2021. to 1:30 p.m.
ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. Feldman explains unique features of the U.S. The bifurcated U.S.
What are the most effective strategies for spread pricing and reimbursement models? What is the best solution to navigate the challenges of the 340B drugpricing program and PBM contracting? What market dynamics and barriers are impacting pricing and demand? How can I ensure compliance with ERISA requirements?
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