You might be surprised by the biggest operational barrier for biosimilars. But with a lower price than its brand-name reference products, would the inconvenience be worth the reward? With a survey of 25 health plan stakeholders, Dan Danielson, Cynthia Miller and Christopher Terrone discover more than half of the participants feel confident their organization can switch to biosimilars. So, why aren’t they? Find out in their recent conversation with Managed Healthcare Executive. https://lnkd.in/e3zmR7Xe PRECISIONvalue
Precision Value & Health’s Post
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Health system leaders need to stay ahead of a rapidly changing treatment landscape. Read our most recent Access Talk POV by Elizabeth to learn more about stakeholder perspectives on preparing for key trends in the coming years and what this could mean for manufacturers. Find out more at https://lnkd.in/ei4k5iax #MosaicGroup #MarketAccess #IPGHealth
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HENRY KOTULA, FHFMA, CPA Senior Financial Executive | Partner | Healthcare Leader | Strategist | Propelling Growth
The Healthcare Industry Mega Trend to Watch in 2024
The Healthcare Industry Mega Trend to Watch in 2024
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My new article is out. You must register (it’s free) to gain access. The folks at Pharmacy U are top notch supporters of pharmacists and pharmacy practice. Be sure to register to follow to learn some of the best practitioners, experts, writers, and thought leaders in the business! #forpharmacy #forpharmacists #pharmacists #pharmacyleadership #leadwell #EveryoneDeservesToBeLedWell #KeepPharmacistsImproving
Here's the latest wisdom from @PharmacyU blogger extraordinaire @JessePharmD. The hope of healthcare – none of us versus all of us https://lnkd.in/g6XYSmP9
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Biosimilars are the most immediate and available solution to high drugs prices - especially for popular and effective biologics. Competition works for other products in the US, so why not medicines? Let's fix the barriers and get affordable access for patients now #biologics #biosimilars #biotech #regulatoryreliance #accessmatters #accessforall #HealthForAll #PassionForHealth
Our VP and Head of U.S. Market Access Thomas M. Newcomer, MBA spoke about why now is the time to engage #biosimilars more into public disclosure as a way to help biosimilars play a role in bringing down healthcare costs. #PassionForHealth #InnovatingAccess
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The rise in patient-centric initiatives in healthcare is driven by several key factors and originally began to materialise from challenges faced post-COVID where it was recognised that change needed to come in order to deal with unprecedented pressures on services. This was a really informative read for me who is still relatively new to the industry, highly recommended - blog here 👇 https://lnkd.in/dypaknia
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Attention Health care providers: Are you confused about the difference between biosimilars and interchangeable biosimilars and are curious to learn more? Check out 9 things about biosimilars and interchangeable biosimilars here: https://bit.ly/45KKIWw
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Senior Manager | Regulatory Expert with 14+ Years' Experience | Driving Successful Approvals & Market Access for Pharmaceuticals | Lectiophile 📚
𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞: 𝐖𝐡𝐚𝐭 𝐁𝐢𝐨𝐬𝐢𝐦𝐢𝐥𝐚𝐫 𝐚𝐧𝐝 𝐈𝐧𝐭𝐞𝐫𝐜𝐡𝐚𝐧𝐠𝐞𝐚𝐛𝐥𝐞 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫𝐬 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐊𝐧𝐨𝐰 In a move that’s bound to stir up some industry buzz, the FDA has dropped a draft guidance for reporting postapproval manufacturing changes in licensed biosimilars and interchangeable products. This guidance elucidates the intricacies of reporting postapproval manufacturing changes for biosimilar and interchangeable products, fulfilling a commitment made in the BsUFA III for fiscal years 2023-2027. For starters, the 𝘍𝘋𝘈 𝘯𝘰𝘸 𝘵𝘳𝘦𝘢𝘵𝘴 𝘪𝘯𝘵𝘦𝘳𝘤𝘩𝘢𝘯𝘨𝘦𝘢𝘣𝘭𝘦 𝘣𝘪𝘰𝘴𝘪𝘮𝘪𝘭𝘢𝘳𝘴 𝘸𝘪𝘵𝘩 𝘵𝘩𝘦 𝘴𝘢𝘮𝘦 𝘳𝘪𝘨𝘰𝘳 𝘢𝘴 𝘣𝘪𝘰𝘴𝘪𝘮𝘪𝘭𝘢𝘳𝘴 𝘸𝘩𝘦𝘯 𝘪𝘵 𝘤𝘰𝘮𝘦𝘴 𝘵𝘰 𝘮𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘪𝘯𝘨 𝘤𝘩𝘢𝘯𝘨𝘦𝘴. This is a big step forward, reflecting the agency’s deeper understanding and experience with these products. 𝑲𝒆𝒚 𝑯𝒊𝒈𝒉𝒍𝒊𝒈𝒉𝒕𝒔: ✓ 𝑪𝒐𝒎𝒑𝒓𝒆𝒉𝒆𝒏𝒔𝒊𝒗𝒆 𝑸&𝑨 𝑭𝒐𝒓𝒎𝒂𝒕: The draft addresses "commonly asked questions," refining our understanding of postapproval manufacturing changes, which was a gray area, particularly for interchangeable products. ✓ 𝑪𝒂𝒕𝒆𝒈𝒐𝒓𝒊𝒛𝒊𝒏𝒈 𝑪𝒉𝒂𝒏𝒈𝒆𝒔: The FDA differentiates post-approval changes into three categories: ► Major Changes: Require a prior approval supplement (PAS). ► Moderate Changes: Necessitate a changes being effected-30 days supplement (CBE-30). ► Minor Changes: Only require annual report filings. ✓ 𝑪𝒐𝒎𝒑𝒂𝒓𝒂𝒃𝒊𝒍𝒊𝒕𝒚 𝑺𝒕𝒖𝒅𝒊𝒆𝒔: Emphasizes using "well-qualified, in-house reference material" to evaluate the impact of manufacturing changes, ensuring consistency and quality of biosimilar products. ✓ 𝑴𝒖𝒍𝒕𝒊𝒑𝒓𝒐𝒅𝒖𝒄𝒕 𝑴𝒂𝒏𝒖𝒇𝒂𝒄𝒕𝒖𝒓𝒊𝒏𝒈: Outlines risks and control measures when introducing biosimilars into multiproduct facilities, highlighting the importance of identity testing to maintain product quality. ✓ 𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆 𝒐𝒏 𝑹𝒆𝒔𝒐𝒖𝒓𝒄𝒆𝒔: FDA recommends referencing three pivotal guidances from 1997, 2021, and the ICH Q5E from 2005, providing a robust framework for manufacturing changes. #Biosimilars #FDA #Pharmaceuticals #RegulatoryAffairs #Biotech #RegulatoryUpdates #Interchangeables
Attention Health care providers: Are you confused about the difference between biosimilars and interchangeable biosimilars and are curious to learn more? Check out 9 things about biosimilars and interchangeable biosimilars here: https://bit.ly/45KKIWw
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Healthcare leaders are rarely able to cast their view deep into the future. Our position in the industry — supporting payers, providers, innovators, and biopharma companies as they solve pressing business problems, capture near term opportunities, and lay the foundation for radical change — affords us a unique opportunity. Our work balances helping healthcare leaders tackle challenges in the next quarter while preparing for the next decade. It's from this unique vantage point that we decided to undertake our Designing for 2035 effort — to assess current trends, evaluate the undercurrents of socioeconomic change that will influence those trends, and identify where there is significant potential for change over the next decade-plus. Read the full report here > https://owy.mn/41Temab #OWHealth #healthcare #HealthcareInnovation
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What are the latest healthcare IT innovations and developments to watch? As industry leaders in healthcare IT, we keep our top position by understanding every sectoral change. Also, we're well aware that everyone needs to stay informed in this rapidly evolving field. That's why we share the most significant monthly developments in this blog series. Keep reading to discover what you need to know about healthcare IT's latest advancements in September: https://lnkd.in/dseN8eqZ #Tiga #HealthcareIT #PharmaIT #Blog
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ZS surveyed 9,500 healthcare consumers and nearly 1,400 healthcare providers in the U.S., U.K., Germany, Sweden, China and Japan to understand what people want from healthcare. And they told us that healthcare system of the future must be accessible, affordable and equitable. In ZS’s annual #FutureofHealth report, we’ve identified ways to bridge healthcare’s gaps. If stakeholders—including #pharma—take action now, we can create a better system for all. Here’s the report: https://lnkd.in/e522Guf7
Future of healthcare insights: Health and patient experience | ZS
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Dan Danielson Cynthia Miller, MD, MPH, CPH, FACP Christopher Terrone Managed Healthcare Executive