FDA Law Blog: Biosimilars

MAY 23, 2025

As FDA stated in guidance in 2023, newer devices should be compared to the benefits and risks of more modern technology. The 510(k) summaries are similarly crucial to the development of new technologies because they allow companies to make substantial equivalence determinations about recently cleared devices.

FDA 59

FDA Regulations Compliance Government 59

FDA Law Blog: Biosimilars

APRIL 14, 2025

The ASCA pilot program concluded in 2023 after seven (7) years based on data demonstrating the pilots objectives were met or surpassed. Prior to November 2023, FDA identified administrative and technical deficiencies in approximately 37% of submissions with ASCA Summary Test Reports during the pilot phase of the program.

Laboratories 59

Laboratories FDA International 59

Drugs.com

AUGUST 25, 2023

25, 2023 -- The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug.

Biosimilars 244

Biosimilars Treatment Drugs 244

Drugs.com

AUGUST 25, 2023

25, 2023 -- The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug.

Biosimilars 237

Biosimilars Treatment Drugs 237

FDA Law Blog: Biosimilars

MARCH 6, 2025

Kijakazi , 2023 U.S. 17, 2023) (citing cases). (For an in-depth review of the history of ALJs and the removal protections enacted by the APA, see Brief of Amicus Curiae Federal Administrative Law Judges Conference 8-20, SEC v. Jarkesy , No. 22-859 (Sept. The constitutionality of ALJs has been a hot legal topic of late. Garland , No.

Government 105

Government Trials Drugs 105

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates.

Drugs 59

Drugs Government 59

Drug Channels

MARCH 28, 2023

Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. d/b/a Drug Channels Institute.

Biosimilars 98

Biosimilars Pharmacy Drugs Production 98

Drug Channels

JANUARY 10, 2023

For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. Each exclusion list now contains about 600 products.

Biosimilars 98

Biosimilars Pharmacy Drugs Production 98

DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, 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 98

Biosimilars Clinical Trials Marketing Production 98

Drug Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar. The Humira biosimilar market has arrived!

Biosimilars 98

Biosimilars Pharmacy Marketing Pharmaceuticals 98

Drug Channels

JULY 18, 2023

The Humira biosimilar market has arrived! This month, nine biosimilar versions of adalimumab launched in the U.S. Surprisingly, two PBMs—Express Scripts and OptumRx—will each offer at least one low-list-price biosimilar option on their main national formularies. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc.

Biosimilars 98

Biosimilars Pharmacy Marketing 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 Drugs Production 98

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 Drugs Production Marketing 98

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

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

Drug Channels

DECEMBER 11, 2023

Click here to see the original post from September 2023. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar.

Biosimilars 75

Biosimilars Pharmacy Production Marketing 75

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 75

Biosimilars Hospitals Pharmacy Drugs 75

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 Drugs Marketing 75

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 75

Biosimilars Pharmacy Drugs Production 75

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

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 74

Biosimilars Drugs 74

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

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

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 Drugs Production 52

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

FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

2140, the Patent Eligibility Restoration Act of 2023 (“ PERA Act ”). IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S.

Biosimilars 76

Biosimilars Production FDA Pharmaceuticals 76

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 Marketing 59

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 Drugs Biosimilars Marketing 98

Drug Channels

JUNE 27, 2023

Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. You can also find my daily posts at @DrugChannels on Twitter , where I have more than 16,500 followers. (I I recommend that you follow me on LinkedIn, because the quality of comments and engagement is much higher than they are on Twitter.) d/b/a Drug Channels Institute.

Pharmacy 98

Pharmacy Drugs Biosimilars 98

FDA Law Blog: Biosimilars

JUNE 27, 2023

Valentine , as a 2023 Rising Star. Karst Awarded WWL: Life Sciences 2023 Global Elite Thought Leader HP&M Director Kurt R. Karst was named by Who’s Who Legal: Life Sciences 2023 as one of only 14 “Global Elite Thought Leaders.” This is an achievement that only around 5% of WWL-listed practitioners were accorded in 2023.

Science 81

Science FDA Approval FDA Drug Development 81

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.

FDA 64

FDA Regulations Marketing Science 64

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 Channels

JULY 23, 2024

These data remain inconvenient for drug pricing flat earthers (#DPFE): When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2023. Insulin has been the first to deflate—and the Humira biosimilar market may be next. You can find links to each company’s data below.

Biosimilars 52

Biosimilars Pharmaceuticals Production Drugs 52

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

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

FDA Law Blog: Biosimilars

MARCH 12, 2023

When the public health emergency ends on May 11, 2023 , so do these exemptions. The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines.

Regulations 98

Regulations Government FDA Drugs 98