Drug Channels

OCTOBER 25, 2022

Sink your fangs into Amgen’s fantastic new report on the biosimilar boom Wicked! Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Mark Cuban tells ghost stories about PBMs. Walgreens terrifies Wall Street with its 340B losses. Physicians think payers cast evil utilization management spells. d/b/a Drug Channels Institute.

Biosimilars 83

Biosimilars Drugs Pharmacy 83

Drug Channels

JANUARY 19, 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. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Each exclusion list contains 400 to 500 products.

Biosimilars 95

Biosimilars Pharmacy Drugs Production 95

Drug Channels

OCTOBER 14, 2022

Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Today’s guest post comes from Steve Callahan, Senior Manager of Market Research at MMIT. Read on for Steve’s insights. d/b/a Drug Channels Institute.

Biosimilars 80

Biosimilars Pharma Companies Marketing Research 80

Drug Channels

SEPTEMBER 13, 2022

By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. Today, I want to highlight three significant—and presumably unintended—drug channel consequences from the hastily-passed IRA legislation.

Biosimilars 74

Biosimilars Pharmacy Hospitals Marketing 74

Drug Channels

JANUARY 28, 2022

Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

Biosimilars 79

Biosimilars Marketing Drugs 79

Drug Channels

APRIL 20, 2022

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.

Biosimilars 85

Biosimilars Pharmacy Drugs Production 85

Drug Channels

MARCH 31, 2022

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.

Biosimilars 81

Biosimilars Pharmacy Drugs 81

Drug Channels

FEBRUARY 28, 2023

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.)

Biosimilars 72

Biosimilars Drugs 72

Agency IQ

APRIL 26, 2024

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).

Biosimilars 40

Biosimilars Science FDA Licensing 40

Drug Channels

APRIL 19, 2022

An ironic postcript: Less than two months after my article was published, Cigna CEO David Cordani bragged about the cost savings from "aggressive adoption" of biosimilars. Anyone want to tell him about the Express Scripts formulary for insulin biosimilars? Read more » Copyright © 2006-2022 Pembroke Consulting, Inc.

Biosimilars 78

Biosimilars Production FDA Drugs 78

Drug Channels

OCTOBER 11, 2022

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!

Pharmaceuticals 56

Pharmaceuticals Biosimilars Licensing Licensing 56

Drug Channels

FEBRUARY 22, 2022

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.

Pharmacy 71

Pharmacy Specialty Pharmacies Biosimilars Licensing 71

Agency IQ

AUGUST 25, 2023

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.

Biosimilars 40

Biosimilars FDA Production Licensing 40

FDA Law Blog: Biosimilars

APRIL 25, 2024

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.

Biosimilars 57

Biosimilars Production FDA Licensing 57

Drug Channels

NOVEMBER 15, 2021

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.

Specialty Pharmacies 67

Specialty Pharmacies Biosimilars Drugs Pharmacy 67

Drug Channels

FEBRUARY 21, 2024

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.

Biosimilars 98

Biosimilars Drugs Government Production 98

FDA Law Blog: Biosimilars

JANUARY 11, 2024

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.

Biosimilars 57

Biosimilars FDA Production Marketing 57

Drug Channels

OCTOBER 29, 2024

Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy Vampiric! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats: Spooky! Prior authorization sinks its fangs into providers’ time Wicked!

Biosimilars 72

Biosimilars Drugs 72

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 56

Biosimilars Pharmacy Drugs Research 56

Drug Channels

MARCH 5, 2024

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.

Pharmacy 84

Pharmacy Biosimilars Drugs Marketing 84

Drug Channels

NOVEMBER 9, 2022

Friday, December 16, 2022 12:00 p.m. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. 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 2023. to 1:30 p.m. Read on for full details on pricing and registration.

Specialty Pharmacies 80

Specialty Pharmacies Pharmacy Biosimilars Drugs 80

Drug Channels

JULY 30, 2024

GoodRx joins the Humira biosimilar price war with Boehringer Ingelheim Averon revealed to be a new buying group for biosimilars for CVS Health and Cardinal Health Why the IRA will be bad news for 340B hospitals Plus, the June 2024 update to my all-time favorite chart. Did the FTC’s compelling interim report prove its case?

Biosimilars 40

Biosimilars Hospitals Drugs 40

Drug Channels

OCTOBER 17, 2022

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.

Biosimilars 57

Biosimilars Pharmacy Therapies Production 57

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development. billion.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

Drug Channels

APRIL 29, 2024

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?

Specialty Pharmacies 81

Specialty Pharmacies Pharmacy Biosimilars Drugs 81

Drug Channels

NOVEMBER 29, 2022

Please join me for my upcoming live video webinar, Drug Channels Outlook 2023 , on December 16, 2022, from 12:00 p.m. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. If you haven't quit Twitter, you can also find my daily posts at @DrugChannels on Twitter , where I have more than 15,500 followers. to 1:30 p.m.

Pharmacy 72

Pharmacy Drugs Marketing Biosimilars 72

Agency IQ

OCTOBER 6, 2023

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.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

FEBRUARY 25, 2022

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

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

Science 40

Science FDA Biosimilars Production 40

Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. for the years 2020 to 2022.

Biosimilars 40

Biosimilars FDA Production Treatment 40

Drug Channels

NOVEMBER 23, 2021

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.

Specialty Pharmacies 82

Specialty Pharmacies Pharmacy Biosimilars Drugs 82

Drug Channels

NOVEMBER 23, 2021

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.

Biosimilars 80

Biosimilars Drugs Hospitals 80

DrugBank

AUGUST 9, 2024

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.

Pharmaceuticals 77

Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 77

Drug Channels

NOVEMBER 23, 2021

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.

Specialty Pharmacies 78

Specialty Pharmacies Pharmacy Biosimilars Drugs 78

Drug Channels

NOVEMBER 22, 2021

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.

Specialty Pharmacies 78

Specialty Pharmacies Pharmacy FDA Biosimilars 78

Drug Channels

JULY 11, 2022

September 14-15, 2022 Sheraton San Diego Hotel & Marina | San Diego, CA www.informaconnect.com/hub-specialty-pharmacy-west. Copyright © 2006-2022 Pembroke Consulting, Inc. Informa Connect's Hub and Specialty Pharmacy Models West. Delivered as a Hybrid Event. Drug Channels, or any of its employees. d/b/a Drug Channels Institute.

Specialty Pharmacies 82

Specialty Pharmacies Pharmacy Biosimilars Compliance 82