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The biosimilar boom for provider-administered drugs continues to accelerate. Net prices in therapeutic classes with biosimilar competition have declined by 60% or more over the past few years. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. drug distribution.
BiosimilarsBiosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.
Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.
Click here to see the original post and comments from January 2022. For 2022, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)— increased the number of drugs they excluded from their standard formularies. d/b/a Drug Channels Institute.
Along with sunshine and fine weather, this vernal equinox has ushered in a crop of new and noteworthy stories: Health inequities in utilization management Insurers compute big white bagging savings The biosimilar boom accelerates The patient upside of manufacturers’ copay support Whoa. CVS Health takes the red pill. to 1:30 p.m.
On March 15, 2022, Drug Channels Institute will release The 2022 Economic Report on U.S. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2022 edition at special discounted prices. Special preorder and launch pricing discounts will be valid through March 28, 2022.
In this issue: Mark Cuban explains his anti-PBM strategy What physicians think about Humira biosimilars States go after PBMs HHS is confused about 340B transparency Plus, The Onion tests your knowledge of United Healthcare’s policies. No promises about future articles. See our forecast to the right.)
Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2022. The Outlook 2022 marks our third annual outlook webinar. Broadcast live on December 17, 2021. to 1:30 p.m.
I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022!
Time to pack away the bathing suit and get serious again—with these curated curiosities combed from the now-barren Drug Channels beach: OptumRx joins the PBM GPO game Pharmacy DIR fees hit $11 billion A terrific resource on state biosimilar laws Patient views on utilization management Plus, my social media success…from a (print) newspaper ad!
Like many of you, I have believed that the Inflation Reduction Act of 2022 (IRA) will encourage Medicare Part D plans to adopt low-list-price products over their high-list/high-rebate counterparts, thereby popping the gross-to-net bubble. Just another IRA-inflicted hit for biosimilars? Actually, maybe not.
This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.
December 12-14, 2022 in Philadelphia, PA www.informaconnect.com/trade. Don’t miss Informa Connect's Trade & Channel Strategies Summit , coming up December 12-14, 2022 in Philadelphia! Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to November 11, 2022.*. Other restrictions may apply.
WHAT YOU WILL LEARN In 2023, the Inflation Reduction Act of 2022 (IRA) began to alter the Medicare Part D program and trigger changes in beneficiary out-of-pocket spending, drug prices, pharmacy economics, and market access strategies. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.
Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).
Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality. Here’s a breakdown of some of the more interesting highlights, statistics and graphics from the FY 2022 report. Recalls Recalls hit a five-year peak in 2022. The PHE also had a dramatic effect on import alerts.
The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.
New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.
Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.
Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.
Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.
Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.
April is over, so it's time to hop into this month’s selection of noteworthy news: CVS Health’s formulary boosts a Humira biosimilar An insurer ditches buy-and-bill to save money for plans—but maybe not for patients?
Recent posts have covered: outcomes-based contracts, copay accumulators, hospitals’ drug profits, biosimilar interchangeability, managed Medicaid, DSCSA, CVS Health’s networks, unintended consequences of congressional drug pricing legislation, Walmart and TRICARE, McKesson’s European retreat, and more. to 1:30 p.m.
BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.
Deloitte 's annual R&D returns analysis for 2022 revealed a continued decline in projected returns for the 20 largest pharmaceutical companies, with a forecasted ROI of just 1.2%, a significant drop from the 1.9% million deaths in 2022. reported in 2021. By 2040, projections show there will be 29.9 million new cases.
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
addresses the Inflation Reduction Act of 2022. There are 241 exhibits in the 2023 edition, compared with 216 in the 2022 edition. A new Section 12.5. In Subsection 12.5.1., we summarize the key provisions of the law that relate to the topics in this report. In Subsection 12.5.2.,
History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 2022 [cited 2023Feb24].
FDA’s approval volume seems to have recovered from a dip in FY 2022, driven mostly by biologics Now that the government’s – and the FDA’s – fiscal year has come to a close, AgencyIQ has reviewed all novel drug approvals for FY 2023. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products.
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