Drug Channels

OCTOBER 31, 2023

CVS Health frightens all but one Humira biosimilar maker away from its formulary. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. It's time for a super-sized Halloween roundup of wicked Drug Channels ’ tales. This month’s tricks and treats: Spooky! The gross-to-net bubble for anti-obesity GLP-1 drugs walks among us.

Biosimilars 98

Biosimilars Pharmacy Drugs 98

Drug Channels

SEPTEMBER 7, 2022

As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. In many therapeutic areas, biosimilars’ market share is approaching 80%. I also offer some thoughts on 2023 and 2024. will face multiple biosimilar competitors. Prices are dropping while adoption accelerates.

Biosimilars 98

Biosimilars Marketing Production Drugs 98

Drug Channels

SEPTEMBER 6, 2023

CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz.

Biosimilars 75

Biosimilars Pharmacy Marketing Drugs 75

Drug Channels

FEBRUARY 7, 2023

As you've surely heard, Amgen has just launched Amjevita, the first non-interchangeable biosimilar of Humira. Its strategy echoes the pricing of the first interchangeable insulin biosimilars— as I predicted in 2021. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

Biosimilars 98

Biosimilars Production Drugs Marketing 98

Drug Channels

APRIL 3, 2024

The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

Biosimilars 52

Biosimilars Pharmacy Production Drugs 52

Drug Channels

APRIL 25, 2023

While we wait for the Phillies turnaround, let’s oil up our gloves, lace up our cleats, and run the bases around this month's biggest hits: Foul ball : OptumRx prefers higher prices for the first Humira biosimilar Strikeout : Copay accumulators hurt health equity Bench warmer : Surprise? d/b/a Drug Channels Institute.

Biosimilars 75

Biosimilars Drugs Pharmacy 75

Drug Channels

MAY 30, 2023

Speaking of PBMs, be sure to join me for my new live video webinar, PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding , on June 23, 2023, from 12:00 p.m. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. to 1:30 p.m. Click here to learn more and sign up.

Biosimilars 98

Biosimilars Hospitals Pharmacy Drugs 98

Drug Channels

MARCH 30, 2023

So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version. Humira sales would be decline by about 37% in 2023—which is at the lower end of its previous erosion projection of 35% to 55%. Click here to see the original post and comments from February 2023.

Biosimilars 98

Biosimilars Pharmacy Production Drugs 98

Drug Channels

DECEMBER 12, 2022

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from September 2022. During Friday’s webinar, I’ll be sharing my updated thoughts about the IRA’s impact on manufacturers, Part D plans, and patient behavior.

Biosimilars 98

Biosimilars Pharmacy Hospitals Marketing 98

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

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

Drug Discovery World

NOVEMBER 9, 2023

Analytical characterisation of biotherapeutics The fifth track of PEGS Europe 2023 is ‘Analytical characterisation of biotherapeutics’, which will feature a range of sessions made up of presentations, talks and posters which address characterisation of novel biotherapeutics, and advances in analytical techniques and approaches.

Engineering 130

Engineering Protein Production Therapies Science 130

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. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. No promises about future articles.

Biosimilars 97

Biosimilars Drugs 97

Drug Channels

NOVEMBER 9, 2022

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. Join Dr. Fein as he helps you and your team get ready for 2023 by outlining key issues and uncertainties that will surely affect your planning. to 1:30 p.m. WHAT YOU WILL LEARN.

Specialty Pharmacies 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

FDA Law Blog: Biosimilars

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”).

Biosimilars 59

Biosimilars FDA Production Packaging 59

The Pharma Data

MARCH 22, 2023

1 Sandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023. 1 Sandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023. “As Sandoz has more than two decades of experience researching, developing and bringing biosimilars to markets across the globe. Head of North America. “As

Biosimilars 40

Biosimilars FDA Approval FDA Pharmacokinetics 40

Drug Discovery World

FEBRUARY 22, 2024

trillion in 2023, according to data analysts GlobalData. The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA).

Marketing 130

Marketing FDA Approval Biosimilars FDA 130

Drug Discovery World

FEBRUARY 20, 2024

The new report says the anticipated growth to 2028 will be fuelled by the expansion of precision medicine, advancements in drug-drug interaction prediction, analysis of patient-derived data, development of biosimilars, and the increasing number of drug candidates. Cardiovascular diseases rank highest in annual fatalities (17.9

Marketing 130

Marketing Biosimilars Drugs Science 130

Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

Biosimilars 40

Biosimilars FDA Production Treatment 40

thought leadership

SEPTEMBER 29, 2023

Generic Drugs, Biosimilars, and Medical Devices. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.),

FDA 45

FDA Small Molecule Biosimilars Government 45

Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The notable new material in this 2023-24 edition includes: New data about commercial pricing and reimbursement for provider-administered biosimilars appears in Section 3.2.2.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

FDA Law Blog: Biosimilars

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. launch would be in early 2024.

Pharmacy 105

Pharmacy FDA FDA Approval Production 105

The Pharma Data

MAY 26, 2023

Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.

Biosimilars 52

Biosimilars Clinical Development Science Therapies 52

Drug Discovery World

DECEMBER 21, 2023

billion in the US in 2023, according to analysts. Adeleke Badejo, Senior Analyst of Immunology at GlobalData, commented: “Barriers to US market growth will primarily result from the loss of patent exclusivity of current biologics, and the subsequent entry of biosimilars to these reference therapies.

Small Molecule 130

Small Molecule Disease Biosimilars Pharmaceutical Companies 130

Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023-24 edition at special discounted prices. pharmaceutical distribution industry.

Pharmaceuticals 52

Pharmaceuticals Pharmacy Biosimilars Licensing 52

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Regulations 64

Regulations FDA Marketing Science 64

Drug Channels

MARCH 14, 2023

I am pleased to announce our new 2023 Economic Report on U.S. Prescription Market (press release) We’re offering special discounted pricing if you order before April 3, 2023. The 2023 Economic Report on U.S. The chart below illustrates the depth and breadth of the 2023 edition. Read on for some additional details.

Pharmacy 98

Pharmacy Drugs Marketing Biosimilars 98

Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment. Read on for Saket’s insights.

Biosimilars 97

Biosimilars Pharmacy Therapies Production 97

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023 edition at special discounted prices. Special preorder and launch pricing discounts will be valid through April 3, 2023.

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

PPD

FEBRUARY 22, 2023

As we look ahead into 2023, there is still uncertainty in the funding landscape, but forecasts are improving. In 2023, the question will be: Have you proven your drug is safe, effective and able to be commercialized? In 2023, the question will be: Have you proven your drug is safe, effective and able to be commercialized?

Biosimilars 52

Biosimilars Clinical Research Marketing Trials 52

Drug Channels

NOVEMBER 14, 2023

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. This event is part of The Drug Channels 2023 Video Webinar Series. to 1:30 p.m.

Pharmacy 98

Pharmacy Biosimilars Drugs Marketing 98

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

FDA Law Blog: Biosimilars

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. By John W.M. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality.

Compliance 59

Compliance FDA Pharmaceuticals Production 59

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40