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🔔 Biosimilars Breakthrough: FDA Firsts of 2024 !!🔔 As we step into the third month of the year, 2024 is emerging to be an important year in the realm of biosimilars with FDA granting a series of pioneering approvals for various biosimilars. Here's a quick rundown of the FDA's notable firsts in the biosimilars arena from Jan 2024 till date: 📆 Mar 07, 2024: The FDA approved Fresenius Kabi's Actemra biosimilar, #Tyenne, in the US. While Biogen's #Tofidence was the first Actemra biosimilar to secure approval in the US, Fresenius Kabi's Tyenne stands out as the first #Actemra biosimilar available in both IV and SC formulations. 🔷 Fresenius Kabi already has a patent settlement agreement with Genentech for the launch of #Tyenne in the US. However, the terms of the agreement and launch timeline currently remains confidential. 📆 Mar 05, 2024: Sandoz received FDA approval with #interchangeability designation for #Jubbonti and #Wyost, making them the first and only approved interchangeable biosimilars for Amgen's Prolia and Xgeva respectively. 🔷 Despite planning to market its denosumab biosimilar under two separate brand names, #Jubbonti and #Wyost, Sandoz filed a single BLA for both. 🔷 Additionally, Sandoz is likely to secure 1 year of market exclusivity for both #Jubbonti and #Wyost, although launch timelines are currently undisclosed due to ongoing patent litigation. 📆 Feb 23, 2024: The FDA approved Alvotech's #adalimumab biosimilar #Simlandi with #interchangeability designation. While Boehringer Ingelheim's Cyltezo and Pfizer's Abrilada previously gained #interchangeability designations, #Simlandi shines as the first high concentration Humira biosimilar to achieve #interchangeability status. 🔷 This makes Alvotech eligible for interchangeable exclusivity for its 40mg/0.4mL injection. 🔷 #Simlandi will marketed in the US by Teva Pharmaceuticals who plans to launch the product at the earliest. #competitiveintelligence #biosimilars #immunology #bonehealth #fdaapproved #regulatoryintelligence #datazymes

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Decentralized Clinical Trials (DCTs) are revolutionizing the drug development process by streamlining operations and accelerating timelines. By decentralizing trial activities and leveraging virtual platforms for data collection and monitoring, sponsors can overcome traditional barriers associated with site-based trials. This agility not only expedites the recruitment and enrollment of participants but also improves patient engagement and retention. As the pharmaceutical industry embraces DCTs, we anticipate a faster pace of innovation and greater efficiency in bringing life-saving treatments to market. #DecentralizedClinicalTrials #DCTelements #CRO #Homevisits #Speelex #Homenursing #DCTmethodologies #clinicaltrials #putpatientfirst

Battle of Biosimilars: 2023 marked a pivotal year in pharmaceuticals with the entry of nine Humira biosimilars, aiming to disrupt the $21 billion sales behemoth. Despite this, the biosimilar wave has seen a tepid response in the U.S., with Amjevita, the first competitor, only garnering $23 million in sales over nine months. Contrastingly, Europe's aggressive adoption of biosimilars, with over 80 approved (till 2022, vs. 33 in the US), showcases a successful model in reducing healthcare costs significantly. Humira-referenced biosimilars in Europe have achieved market shares of 75% or higher, demonstrating the potential for biosimilars to offer substantial savings. Yet, in the U.S., various factors such as patent thickets, complex rebate system, and regulations around interchangeability have stifled biosimilar uptake. For instance, Humira's biosimilars have barely scratched the surface, with sales figures like $2 million for Hadlima and $1.4 million for Yusimry lagging far behind expectations. As we look to the future, it's clear that unlocking biosimilars' full potential requires not just regulatory action but a shift in market dynamics to favor these cost-effective alternatives. Further reads - 1. Forbes - Biosimilars not gaining traction: https://lnkd.in/dxd9RX_h 2. Forbes - IRA curbs patent practices: https://lnkd.in/dY2rn2AG 3. AJMC - Uptake of biosimilars: https://lnkd.in/ddyXp6C7 4. Healthcare Brew - https://lnkd.in/d67BkuDy #biosimilars #healthcarecosts

Humira, a blockbuster drug, defied expectations by clinging to market share even after its patent expired. But the tide may be turning. CVS just announced a major shift in their formularies, prioritizing biosimilars over Humira. What does this mean? It could be a tipping point for biosimilar adoption across the industry. Click the link to read the full article ➡ https://lnkd.in/gR3MuyTp #pharmacy  #biosimilars  #drugmarket

Let's talk #Stelara® (ustekinumab) for a moment. It will be the next higher-cost biological with biosimilars coming in 2025. And the next big one for self-funded plans to manage. If you're a plan fiduciary, you should be asking your #PBMs how they're going to handle it now in prep for the biosimilars coming in 2025. -According to the brand manufacturer's website, the list price of Stelara® is $25,497.12 every 8 weeks for the 90 mg dose as of March 2022. After initial doses and based upon the indication, it's used every 8 or 12 weeks. FDA Biosimilars thus far: 1. Wezlana (ustekinumab-auub) - The first Stelara biosimilar to be approved by the FDA, Wezlana is interchangeable with Stelara and is manufactured by Amgen.  2. Selarsdi (ustekinumab-aekn) - Developed and manufactured by Alvotech and Teva Pharmaceuticals, Selarsdi is approved for both adults and children. It is expected to be marketed in the US in February 2025.  3. Ustekinumab-ttwe - Sandoz will commercialize this biosimilar in the US, and it is expected to be one of the first to launch in the US. *Indications may vary Ask your PBMs: 1. If you have access to your data as a self-funded plan (you should, it's your data) - check and see if you have any on the plan now. If not, ask if there's any Stelara on the plan at present. 2. Which biosimilar will be on formulary? 3. By when? (Hint - the PBM should have it coming early in 2025.) 4. Will it be a high cost with drug rebates, or low cost without--or worst of both worlds, both, and then which one is the PBM choosing? (They'll probably be going high with drug rebates...) 5. If there are rebates, what will be coming back to the plan? 6. What will the members' copays be? 7. What will be the plan's cost? -Note: There is a high dose form of Stelara that hides out over in your medical benefits, because it is IV. Ask your PBM about that one too.... https://lnkd.in/geecGUnR Last, if you're a large employer with 1000+ employees, consider hiring a #pharmacist to manage your healthcare benefits plan and #prescriptiondrug spend. They are worth their weight in gold! #pharmacy

More for self-funded plan fiduciaries to ask....for plans in 2025. There are some high-cost biologicals coming off patent in 1Q25. I posted about Stelara earlier this week: https://lnkd.in/gac4wjTv Next up, Soliris® (eculizumab). First off, this an IV-infused drug - so look for claims over in your MEDICAL benefits, not the PHARMACY benefits. You won't find it at the corner drugstore. I couldn't find a list price on the manufacturer's site, but the average sales price according to the Oct preliminary ASP file with CMS for a maintenance dose (1200 mg) is $26,955.96, and is typically dosed every 2 weeks after loading doses. If maintained, we're talking over $700,000 per patient per year on this therapy. Second, there are a few biosimilars that have been approved thus far in 2024: 1. The first, Bkemv (eculizumab-aeeb, Amgen), was approved in May 2024 (and interchangeable) 2. The second, Epysqli (eculizumab-aagh, Samsung Bioepis) approved in July 2024. The biosimilars should be out at the end of 1Q2025. Questions to ask your #PBM, your #MedicalCarrier, and your #broker: (And yes, keep in mind this drug is rarely in the pharmacy benefit, so you'll need to ask both the PBM and the medical carrier): 1. Do we have any Soliris or Ultomiris claims? 2. If so, what is the plan for the biosimilars here? 3. What will be the preferred biosimilar on the drug formulary? 4. What will be the cost to the member? 5. What will be the cost to the plan? 6. Are there any rebates on any of the biosimilars, and if so, what's coming back to the plan, and how often will it come back to the plan? (Hint, medical carriers often stare blankly when plans ask about medical drug rebates. Push them on this, because there ARE rebates on medical drugs.) 7. Are there any savings programs on the other side of the benefits (like the pharmacy benefits) if the PBM handles the drug instead of the medical benefit? (This is why you need to ask both the PBM and the medical carrier here.) 8. What about Ultomiris? (This is a longer-acting biological than Soliris and not coming off of patent in early 2025.)

🚨 Big News in Biopharma! 🚨 The FTC is backing the FDA’s proposal to streamline biosimilar interchangeability! 📈💊 This new draft guidance could make it easier for biosimilars to gain interchangeability designations by using existing data instead of conducting new clinical studies. 🏷️🧪 This change would allow pharmacists to substitute biosimilars for brand-name biologics without additional prescriber approval, boosting competition and patient access. 🏥✅ With 56 biosimilars approved but only 13 interchangeable so far, this could greatly increase the number of interchangeable options. 📊🔬 Scripta Insights is ready to help patients navigate through these exciting changes! 🌐✨ #Biosimilars #FDA #FTC #HealthcareInnovation #PatientAccess #Biopharma #DrugPricing Scripta Insights

Revolutionizing the future of healthcare: Biosimilars are set to reshape the pharmaceutical landscape with affordability, accessibility, and unparalleled clinical outcomes. Head to our website to read more: https://lnkd.in/dUAvvA6K Karthik Kondepudi Dr. Vikas Gupta Sridevi Khambhampaty #indiamedtoday #healthcare #healthcarenews #healthcareupdates

The 2024 Access to Medicine Index finds that pharmaceutical companies are not fully leveraging their potential to expand access in underserved regions. Collaborative activities, such as voluntary licensing agreements and technology transfers, which can have a significant impact on improving the local availability of medicine globally, are not being maximised by companies. Head to our website to read more: https://lnkd.in/g_ZYnpUX Access to Medicine Foundation Jayasree Iyer #indiamedtoday #healthcare #healthcarenews #healthcareupdates