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News
Balancing Clinical Outcomes and Cost: The Value of Biosimilars in Retinal Disease Management
09/26/2025
Juliet Gallagher
A recent study examining the impact of retinal diseases highlights their significant clinical, social, and economic burden.
A recent study examining the impact of retinal diseases highlights their significant clinical, social, and economic burden.
A recent study examining the...
09/26/2025
First Report Managed Care
News
Policy Impact: FDA’s Interchangeability Designation Expands Biosimilar Access
09/25/2025
Juliet Gallagher
Insulin glargine, marketed as Semglee and its biosimilar insulin glargine-yfgn, was granted interchangeable status, allowing pharmacists to substitute it for the branded originator without requiring prescriber intervention. A new economic...
Insulin glargine, marketed as Semglee and its biosimilar insulin glargine-yfgn, was granted interchangeable status, allowing pharmacists to substitute it for the branded originator without requiring prescriber intervention. A new economic...
Insulin glargine, marketed as...
09/25/2025
First Report Managed Care
News
How Timing Shapes Biosimilar Success: Insights from US Market Data
09/24/2025
Juliet Gallagher
A recent study published in Value in Health sheds light on the competitive dynamics of biosimilar drugs in the US, specifically examining whether first-mover advantages resemble those seen in generic drug markets.
A recent study published in Value in Health sheds light on the competitive dynamics of biosimilar drugs in the US, specifically examining whether first-mover advantages resemble those seen in generic drug markets.
A recent study published in...
09/24/2025
First Report Managed Care
News
Biosimilars Match Humira in Structure, Show Greater Stability Under Real-World Stress
09/22/2025
Juliet Gallagher
A new analytical study underscores how advanced nuclear magnetic resonance (NMR) spectroscopy can sharpen head-to-head comparisons between Humira (adalimumab) and its biosimilars—particularly when products are challenged under real-world...
A new analytical study underscores how advanced nuclear magnetic resonance (NMR) spectroscopy can sharpen head-to-head comparisons between Humira (adalimumab) and its biosimilars—particularly when products are challenged under real-world...
A new analytical study...
09/22/2025
First Report Managed Care
News
$3.2 Million Saved Through Biosimilar Substitution in Rheumatology Clinics
09/19/2025
Juliet Gallagher
A study published in the Journal of Clinical Rheumatology found that a recent initiative at a large academic medical center significantly increased biosimilar uptake and generated substantial cost savings through targeted interventions.
A study published in the Journal of Clinical Rheumatology found that a recent initiative at a large academic medical center significantly increased biosimilar uptake and generated substantial cost savings through targeted interventions.
A study published in the Journal...
09/19/2025
First Report Managed Care
News
Pharmacists Lead, Physicians Lag? Provider Perspectives on Biosimilars and Interchangeability
09/18/2025
Juliet Gallagher
A new cross-sectional survey of 249 US outpatient clinicians—150 physicians and 99 pharmacists who treat immunologic conditions—offers a timely snapshot of how front-line decision-makers view biosimilars and the US Food and Drug...
A new cross-sectional survey of 249 US outpatient clinicians—150 physicians and 99 pharmacists who treat immunologic conditions—offers a timely snapshot of how front-line decision-makers view biosimilars and the US Food and Drug...
A new cross-sectional survey of...
09/18/2025
First Report Managed Care
News
Payer-Driven Biosimilar Preferences Create Financial and Operational Strain for Health Systems
09/17/2025
Juliet Gallagher
The expansion of US Food and Drug Administration (FDA)-approved biosimilars has been heralded as a major advancement for lowering healthcare costs in the US, with the potential to reduce both system-wide expenditures and patient out-of-pocket...
The expansion of US Food and Drug Administration (FDA)-approved biosimilars has been heralded as a major advancement for lowering healthcare costs in the US, with the potential to reduce both system-wide expenditures and patient out-of-pocket...
The expansion of US Food and...
09/17/2025
First Report Managed Care
News
Biologics and Biosimilars Reshape Care With Targeted Therapies and Cost Savings
09/16/2025
Lisa Kuhns, PhD, MD
Both biologics and biosimilars are transforming patient care by delivering more targeted therapies and expanding access through cost savings, according to Andrew Darkow, PharmD, MBA, BCPS, during his presentation at the American Association...
Both biologics and biosimilars are transforming patient care by delivering more targeted therapies and expanding access through cost savings, according to Andrew Darkow, PharmD, MBA, BCPS, during his presentation at the American Association...
Both biologics and biosimilars...
09/16/2025
First Report Managed Care
News
FDA Issues Final Guidance on Biosimilar Prior Approval Supplements
09/10/2025
Grace Taylor, MS, MA
The US Food and Drug Administration (FDA) has finalized guidance clarifying 6 categories of biosimilar prior approval supplements, setting review goals that could shape timelines for new indications and payer coverage decisions.
The US Food and Drug Administration (FDA) has finalized guidance clarifying 6 categories of biosimilar prior approval supplements, setting review goals that could shape timelines for new indications and payer coverage decisions.
The US Food and Drug...
09/10/2025
First Report Managed Care
News
AAM White Paper Spotlights Legislative Path to Breaking Biosimilar Patent Barriers
08/18/2025
Grace Taylor, MS, MA
A recent white paper from the Association for Accessible Medicines exposes how brand-name drug patent tactics block biosimilar access and urges Congress to act on 3 key reforms to lower drug costs.
A recent white paper from the Association for Accessible Medicines exposes how brand-name drug patent tactics block biosimilar access and urges Congress to act on 3 key reforms to lower drug costs.
A recent white paper from the...
08/18/2025
First Report Managed Care

Behind the Bill

Behind the Bill
The Senate’s $3 Trillion Deal. Tax Relief Now, Medicaid Coverage Loss Later?
07/02/2025
Katie Hayes, MJ
The Senate has done it. After weeks of behind-the-scenes wrangling and last-minute amendments, lawmakers have passed a sprawling tax-and-spending megabill that makes good on a long-standing Republican goal: making the 2017 Trump tax cuts...
The Senate has done it. After weeks of behind-the-scenes wrangling and last-minute amendments, lawmakers have passed a sprawling tax-and-spending megabill that makes good on a long-standing Republican goal: making the 2017 Trump tax cuts...
The Senate has done it. After...
07/02/2025
First Report Managed Care
Behind the Bill
When a Cap Isn’t Just a Cap: How a Provider Tax Proposal Could Reshape Medicaid Financing
06/25/2025
Katie Hayes, MJ
In Washington, the most consequential policies are often buried in the fine print. One such detail in the Senate Finance Committee’s latest tax and spending proposal would gradually cap provider taxes—a core funding tool states use to pull in...
In Washington, the most consequential policies are often buried in the fine print. One such detail in the Senate Finance Committee’s latest tax and spending proposal would gradually cap provider taxes—a core funding tool states use to pull in...
In Washington, the most...
06/25/2025
First Report Managed Care
Behind the Bill
Rewriting the Safety Net? Inside the Senate’s Changes to Medicaid and the ACA
06/18/2025
Katie Hayes, MJ
Over the past few weeks, I’ve been following the progress of the One Big Beautiful Bill Act (OBBBA), which started in the House with sweeping tax reforms and some eye-catching health care proposals. Now, the Senate has released its (highly...
Over the past few weeks, I’ve been following the progress of the One Big Beautiful Bill Act (OBBBA), which started in the House with sweeping tax reforms and some eye-catching health care proposals. Now, the Senate has released its (highly...
Over the past few weeks, I’ve...
06/18/2025
First Report Managed Care
Behind the Bill
How States Might Respond to the One Big Beautiful Bill Act
06/11/2025
Katie Hayes, MJ
With the One Big Beautiful Bill Act (OBBBA) still in the hands of the Senate, much of the national conversation has centered on what this legislation would do to federal coverage programs. But regardless of how the federal process unfolds,...
With the One Big Beautiful Bill Act (OBBBA) still in the hands of the Senate, much of the national conversation has centered on what this legislation would do to federal coverage programs. But regardless of how the federal process unfolds,...
With the One Big Beautiful Bill...
06/11/2025
First Report Managed Care
Behind the Bill
Is the Affordable Care Act on the Chopping Block? What the One Big Beautiful Bill Act Tells Us.
06/04/2025
Katie Hayes, MJ
It’s been weeks of headline-grabbing debate over Medicaid work requirements, and the “One Big Beautiful Bill Act” remains in the Senate as they deliberate over several health care provisions. While the Medicaid provisions sparked most of the...
It’s been weeks of headline-grabbing debate over Medicaid work requirements, and the “One Big Beautiful Bill Act” remains in the Senate as they deliberate over several health care provisions. While the Medicaid provisions sparked most of the...
It’s been weeks of...
06/04/2025
First Report Managed Care
Behind the Bill
From House to Senate: The Journey of Cutting Medicaid
05/28/2025
Katie Hayes, MJ
Last week, the House of Representatives narrowly passed the One Big Beautiful Bill Act (HR 1, 119th Congress) by a single vote, sending the sweeping tax and spending reconciliation package, backed by President Trump, to the Senate. With its...
Last week, the House of Representatives narrowly passed the One Big Beautiful Bill Act (HR 1, 119th Congress) by a single vote, sending the sweeping tax and spending reconciliation package, backed by President Trump, to the Senate. With its...
Last week, the House of...
05/28/2025
First Report Managed Care
Behind the Bill
Eligibility, Paperwork, and Penalties: The Not-So-Hidden Costs of Medicaid ‘Reform’
05/21/2025
Katie Hayes, MJ
It’s been another eventful week in health policy—a phrase that’s quickly becoming routine. This time, House Republicans advanced a sweeping budget reconciliation bill, designed to implement elements of the March budget resolution, with a...
It’s been another eventful week in health policy—a phrase that’s quickly becoming routine. This time, House Republicans advanced a sweeping budget reconciliation bill, designed to implement elements of the March budget resolution, with a...
It’s been another eventful week...
05/21/2025
First Report Managed Care
Behind the Bill
A Busy Week in Drug Pricing Policy: Aligning US Drug Prices With Global Standards?
05/14/2025
Katie Hayes, MJ
It’s been a busy few days for drug pricing policy. While I’d love to dig into the details of both President Trump’s latest executive order and the newest Republican bill that would cut Medicaid spending, we don’t have the time—and this isn’t...
It’s been a busy few days for drug pricing policy. While I’d love to dig into the details of both President Trump’s latest executive order and the newest Republican bill that would cut Medicaid spending, we don’t have the time—and this isn’t...
It’s been a busy few days for...
05/14/2025
First Report Managed Care
BEHIND THE BILL
When Agencies Lose Power: How 3 Seismic Shifts are Transforming Pharmaceutical Regulation
05/07/2025
Katie Hayes, MJ
In the span of just 9 months, the landscape of administrative law has undergone a transformation so profound that pharmaceutical executives, health care providers, and patients alike are struggling to navigate the new terrain. The Supreme...
In the span of just 9 months, the landscape of administrative law has undergone a transformation so profound that pharmaceutical executives, health care providers, and patients alike are struggling to navigate the new terrain. The Supreme...
In the span of just 9 months,...
05/07/2025
First Report Managed Care
Behind the Bill
The Medicare Paradox, Part 3: Strategic Trade Doesn’t Have to be a Zero-Sum Game
05/07/2025
Katie Hayes, MJ
Over the past 2 weeks, I’ve examined the growing friction between the Section 232 pharmaceutical tariff investigations and the Medicare drug pricing reforms authorized by the Inflation Reduction Act (IRA). These 2 policy agendas—industrial...
Over the past 2 weeks, I’ve examined the growing friction between the Section 232 pharmaceutical tariff investigations and the Medicare drug pricing reforms authorized by the Inflation Reduction Act (IRA). These 2 policy agendas—industrial...
Over the past 2 weeks, I’ve...
05/07/2025
First Report Managed Care

Trending Articles

Shannon Smith, RN, BSN
Commentary
Navigating the CY 2025 CMS Physician Fee Schedule Proposals: Strategic Insights for Health Care Leaders
09/30/2024
Shannon Smith, RN, BSN
The Centers for Medicare & Medicaid Services (CMS) has released its calendar year (CY) 2025 physician fee schedule proposals. In this commentary, an expert breaks down the key components and their implications for health care organizations.
The Centers for Medicare & Medicaid Services (CMS) has released its calendar year (CY) 2025 physician fee schedule proposals. In this commentary, an expert breaks down the key components and their implications for health care organizations.
The Centers for Medicare &...
09/30/2024
First Report Managed Care
Behind the Bill
Unpredictable Polls and Uncharted Policies in the 2024 Elections
10/23/2024
Katie Hayes, MJ
With the 2024 elections just 13 days away, everyone has one question: What happens next? The stakes are particularly high for health policy, but there’s a cloud of uncertainty hanging over the predictions—especially when it comes to polling...
With the 2024 elections just 13 days away, everyone has one question: What happens next? The stakes are particularly high for health policy, but there’s a cloud of uncertainty hanging over the predictions—especially when it comes to polling...
With the 2024 elections just 13...
10/23/2024
First Report Managed Care
News
Latest Formulary Exclusions from Top PBMs Demonstrate Issues in the Drug Pricing Landscape
02/21/2024
Dean Celia
Experts highlight the impact of the "warped incentives" in drug pricing's gross-to-net bubble, revealing that despite significant discounts, certain biosimilars are excluded from the formularies of major pharmacy benefit managers, leading to...
Experts highlight the impact of the "warped incentives" in drug pricing's gross-to-net bubble, revealing that despite significant discounts, certain biosimilars are excluded from the formularies of major pharmacy benefit managers, leading to...
Experts highlight the impact of...
02/21/2024
First Report Managed Care
Owens
Podcasts
Understanding the Impact of Formulary Exclusions on Medication Adherence
03/28/2024

Featuring Gary Owens, MD, president of Gary Owens Associates

Featuring Gary Owens, MD, presid...
Join us as guest expert Gary Owens discusses how formulary exclusions can impact patient medication adherence and lead to adverse economic outcomes, making the need for non-medical switching and formulary exception requests an important issue...
Join us as guest expert Gary Owens discusses how formulary exclusions can impact patient medication adherence and lead to adverse economic outcomes, making the need for non-medical switching and formulary exception requests an important issue...
Join us as guest expert Gary...
03/28/2024
First Report Managed Care
Conference Coverage
Pharmaceutical Industry Trend and Prediction Highlights from AMCP 2024
04/26/2024
Hannah Musick
A keynote session at AMCP 2024 outlined pharmaceutical industry trends and predictions for pharmacy benefits management (PBMs), including challenges and disruptors like the Inflation Reduction Act (IRA), changing consumer preferences, rising...
A keynote session at AMCP 2024 outlined pharmaceutical industry trends and predictions for pharmacy benefits management (PBMs), including challenges and disruptors like the Inflation Reduction Act (IRA), changing consumer preferences, rising...
A keynote session at AMCP 2024...
04/26/2024
First Report Managed Care

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