FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

Pharmacy 59

Pharmacy Regulations Compliance Government 59

Drug Channels

MARCH 8, 2023

Next week, Drug Channels Institute will release our 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. drug pricing, reimbursement, and dispensing system. The largest 15 pharmacies accounted for more than 75% of total dispensing revenues from retail, mail, long-term care, and specialty pharmacies.

Pharmacy 98

Pharmacy Specialty Pharmacies Marketing Drugs 98

Drug Channels

DECEMBER 7, 2021

It’s time for our annual deep dive into employer-sponsored coverage for prescription drugs. For 2021, employers backed away slightly from high-deductible health plans. However, their pharmacy benefit designs increased the use of coinsurance for specialty and fourth-tier drugs. d/b/a Drug Channels Institute.

Pharmacy 98

Pharmacy Drugs 98

Drug Channels

FEBRUARY 9, 2021

On March 16, 2021, Drug Channels Institute will release The 2021 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. drug pricing, reimbursement, and dispensing system. Special preorder and launch pricing discounts will be valid through March 28, 2021. d/b/a Drug Channels Institute.

Pharmacy 52

Pharmacy Drugs 52

Drug Channels

MARCH 1, 2022

The Centers for Medicare & Medicaid Services (CMS) has recently released its 2022 data on enrollment in Medicare Part D prescription drug plans (PDPs). Our exclusive analysis of these numbers finds that for 2022, an astounding 99% of seniors are enrolled in the wonderland of PDPs with preferred pharmacy networks. million people.

Pharmacy 98

Pharmacy Marketing Drugs 98

Drug Channels

OCTOBER 19, 2021

Hospitals and health systems are rapidly expanding their internal specialty pharmacies—and they’re using questionable tactics to boost revenues and profits. Nearly two-thirds of the larger health system specialty pharmacies operate as the exclusive pharmacy within self-insured health systems’ networks. Hope to see you there!

Specialty Pharmacies 96

Specialty Pharmacies Pharmacy Hospitals International 96

Drug Channels

DECEMBER 15, 2021

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2022. Click here to see the original post and comments from August 2021. I especially enjoyed the cool visualizations of Drug Channels Institute’s industry data. d/b/a Drug Channels Institute.

Pharmacy 98

Pharmacy Drugs 98

Drug Channels

JUNE 7, 2021

National Association of Specialty Pharmacy (NASP) 2021 Annual Meeting & Expo. September 27-30, 2021 | Marriott Marquis, Washington, D.C. The National Association of Specialty Pharmacy (NASP) returns to Washington, D.C. The National Association of Specialty Pharmacy (NASP) returns to Washington, D.C.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Hospitals Drugs 52

Drug Channels

DECEMBER 15, 2023

This week, I’m rerunning some popular posts while I prepare for today’s Drug Channels Outlook 2024 live video webinar. Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. billion (+22.3%) higher than its 2021 counterpart. d/b/a Drug Channels Institute. billion (+$2.6

Pharmacy 98

Pharmacy Hospitals Drugs 98

Drug Channels

NOVEMBER 23, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble Reconsidering Amazon P.S. Please join the nearly 13,000 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter. d/b/a Drug Channels Institute.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

AUGUST 31, 2021

Charlotte Morabito at CNBC has put together “Why Pharmacies Overcharge,” an entertaining and provocative video on the pharmacy industry and its generic prescription pricing. I especially enjoyed the cool visualizations of Drug Channels Institute’s industry data. from your friendly neighborhood blogger at Drug Channels.

Pharmacy 97

Pharmacy Drugs 97

Drug Channels

OCTOBER 12, 2021

specialty pharmacies—via white, brown, and clear bagging—continue to displace buy-and-bill distribution channels for provider-administered oncology drugs. Check out the latest 2021 data below. The battle for the specialty patient pits hospitals against insurers—and their respective specialty pharmacies.

Specialty Pharmacies 97

Specialty Pharmacies Pharmacy Hospitals Pharmaceuticals 97

Drug Channels

SEPTEMBER 24, 2023

Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. billion (+22.3%) higher than its 2021 counterpart. Every 340B covered entity type experienced double-digit growth, despite drug prices that grew more slowly than overall inflation. d/b/a Drug Channels Institute. billion (+$2.6

Pharmacy 96

Pharmacy Hospitals Drugs 96

Drug Channels

NOVEMBER 23, 2021

Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. Happy Thanksgiving, everyone!

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

Drug Channels

NOVEMBER 3, 2020

Last week , I highlighted the largest pharmacy chains that will participate in the 2021 Medicare Part D prescription drug plans (PDP). The Centers for Medicare & Medicaid Services (CMS) continues to take a hands-off approach to pharmacy networks. d/b/a Drug Channels Institute.

Independent Pharmacies 52

Independent Pharmacies Pharmacy Drugs 52

Drug Channels

NOVEMBER 30, 2021

ICYMI, CVS Health recently announced that it will close about 900 of its retail pharmacies. The pharmacy shakeout is accelerating, as smaller competitors exit and larger companies reduce store count. To help you make sense of CVS’s move, below I outline 10 crucial forces of change reshaping the retail pharmacy industry.

Pharmacy 98

Pharmacy Drugs 98

Drug Channels

APRIL 26, 2022

In this issue: Green Monster : The 340B market hits new highs in 2021 Not-Free Agents : Big 340B profits for CVS, Walgreens, Express Scripts, et al Batter Up : Fixing the insulin market Pinch Hitters : Walgreens bets on robots Plus, Dr. Glaucomflecken helps UnitedHealthcare celebrate Doctors’ Day! d/b/a Drug Channels Institute.

Pharmacy 98

Pharmacy Specialty Pharmacies Doctors Drugs 98

Drug Channels

SEPTEMBER 23, 2021

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Update: Buy-and-Bill Market Trends. Click here to see the original post and comments from May 2021. Last week, Cigna released its earnings for the first quarter of 2021. d/b/a Drug Channels Institute.

Pharmacy 97

Pharmacy Marketing Drugs 97

Drug Channels

JUNE 29, 2022

Through the Drug Channels Institute, I strive to provide you with fact-based and balanced coverage—along with links to source materials so you can make up your own mind. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. This Feed is for personal non-commercial use only.

Pharmacy 98

Pharmacy Drugs 98

Drug Channels

NOVEMBER 22, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble CVS acknowledges how its PBM profits from 340B Reconsidering Amazon Plus, the FDA preps you for Thursday with a regulatory soup review. d/b/a Drug Channels Institute.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy FDA Biosimilars 98

Drug Channels

NOVEMBER 18, 2021

In my previous post , I highlighted the largest pharmacy chains that will participate in the 2022 Medicare Part D prescription drug plans (PDP). Smaller pharmacies’ rejection of Part D preferred networks shows that they are figuring out how to survive a highly challenging retail environment. d/b/a Drug Channels Institute.

Pharmacy 75

Pharmacy Drugs 75

Drug Channels

AUGUST 25, 2021

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!

Biosimilars 83

Biosimilars Pharmacy Drugs Research 83

Drug Channels

MARCH 2, 2021

The Centers for Medicare & Medicaid Services (CMS) has recently released its 2021 data on enrollment in Medicare Part D prescription drug plans (PDPs). Our exclusive analysis of these numbers finds that for 2021, an astounding 99% of seniors are enrolled in PDPs with preferred pharmacy networks.

Pharmacy 52

Pharmacy Drugs 52

Drug Channels

MARCH 1, 2022

The Centers for Medicare & Medicaid Services (CMS) has recently released its 2022 data on enrollment in Medicare Part D prescription drug plans (PDPs). Our exclusive analysis of these numbers finds that for 2022, an astounding 99% of seniors are enrolled in the wonderland of PDPs with preferred pharmacy networks.

Pharmacy 98

Pharmacy Marketing Drugs 98

Drug Channels

OCTOBER 20, 2020

Last week, open enrollment began for the 2021 Medicare Part D plans. . Our exclusive analysis of these data reveals that preferred cost sharing pharmacy networks will maintain their dominance as an established component of Part D benefit design. . As always, Drug Channels brings you the news—so you don't have to get it yourself.

Pharmacy 52

Pharmacy Independent Pharmacies Drugs 52

Drug Channels

NOVEMBER 2, 2021

Our exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that preferred cost sharing pharmacy networks will maintain their dominance as an established component of Part D benefit design. For 2022: 98% of stand-alone Medicare Part D prescription drug plans (PDP) will have a preferred network.

Pharmacy 98

Pharmacy Independent Pharmacies Drugs 98

Drug Channels

FEBRUARY 23, 2021

Let’s melt away this foul February with our monthly selection of scorching news from around the drug channel. In this issue: Payers confess: Patients lose from copay accumulators Humana joins the Express Scripts GPO Hospitals vs. PBMs over specialty pharmacy white bagging Let’s all follow the Buy-and-Bill Dollar!

Pharmacy 52

Pharmacy Specialty Pharmacies Hospitals Independent Pharmacies 52

Drug Channels

OCTOBER 15, 2021

Jayne discusses changes in the life science and specialty pharmacy industries since the COVID-19 pandemic began. She highlights three key trends that pharma companies, plan sponsors, and others will consider as we head to the upcoming Asembia Specialty Pharmacy Summit (October 26 to 29 in Las Vegas). d/b/a Drug Channels Institute.

Specialty Pharmacies 75

Specialty Pharmacies Pharmacy Pharma Companies Science 75

Drug Channels

FEBRUARY 2, 2021

Time to update Drug Channels' exclusive look at independent pharmacy owners’ business economics. Our analysis reveals that despite what you may have heard, many independent pharmacies have figured out how to survive a highly challenging environment. Retail pharmacy profits have rebounded—or at least not fallen any further.

Pharmacy 52

Pharmacy Independent Pharmacies Drugs 52

Drug Channels

JUNE 15, 2021

Drug Channels Institute’s latest review of contract pharmacies in the 340B Drug Pricing Program reveals that an astonishing 30,000 pharmacy locations—half of the entire U.S. pharmacy industry—now act as contract pharmacies for the hospitals and other healthcare providers that participate in the 340B program.

Pharmacy 52

Pharmacy Hospitals Drugs 52

Drug Channels

SEPTEMBER 21, 2021

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Update: Buy-and-Bill Market Trends. Click here to see the original post and comments from May 2021. In Drug Channels Institute's list of the top 15 pharmacies of 2020 , we show that many of the largest U.S.

Specialty Pharmacies 91

Specialty Pharmacies Pharmacy Marketing Drugs 91

Drug Channels

SEPTEMBER 28, 2021

Curl up with your favorite pumpkin-spiced blog and savor these stories harvested from the Drug Channels patch: Fresh insights about hospitals’ specialty drug profits SSR Update: Drug prices keep dropping My $0.02 Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

Hospitals 81

Hospitals Biosimilars Pharmacy International 81

Drug Channels

APRIL 27, 2021

While we all roll up our sleeves for a full reopening, let’s spring into this month’s selection of noteworthy news: Thoughts on Cigna’s payments to patients for non-medical switching 340B’s explosive specialty pharmacy growth An excellent analysis of GoodRx Plus, my $0.02 drug pricing policy. d/b/a Drug Channels Institute.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Biosimilars Drugs 52

Drug Channels

OCTOBER 27, 2021

So grab your pillow case and stuff it with treats from the great Drug Channels pumpkin patch: Spooky! PBMs are conjuring a terrifying number of formulary exclusions for oncology drugs Eerie! drug spending shambles into the middle of the herd Plus, The Onion summons the only humorous article about CRISPR. Brrr.did you hear that?

Biosimilars 97

Biosimilars Hospitals Independent Pharmacies Pharmacy 97

Drug Channels

MAY 18, 2021

It’s time for Drug Channels Institute’s annual update of the number of U.S. specialty pharmacies. As you will note below, the specialty pharmacy industry remains quite diverse— despite the concentration of dispensing revenues within a small number of companies. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Marketing Hospitals 52

Drug Channels

NOVEMBER 23, 2021

Please join me for my upcoming live video webinar, Drug Channels Outlook 2022 , on December 17, 2021, from 12:00 p.m. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. Happy Thanksgiving, everyone!

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Biosimilars Drugs 52

Drug Discovery World

APRIL 10, 2023

Could India become an important centre of drug discovery innovation? India is traditionally known as ‘the pharmacy of the world’ due to its huge pharmaceuticals manufacturing capacity and high quantity of exports, particularly generic medicines and vaccines. In 2021, a DDW article stated: “There is work to be done.

Vaccine 130

Vaccine Pharmaceuticals Drugs Science 130