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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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

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. I can only barely scratch the surface in this article, so feel free to share your own thoughts in the comments below or on social media.

Biosimilars 74

Biosimilars Pharmacy Hospitals Marketing 74

Drug Channels

JULY 20, 2022

Cut through the steamy summer haze with our refreshing selection of articles and insights. In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy.

Biosimilars 81

Biosimilars Pharmacy Drugs Marketing 81

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? Alas, I’m sad to report that the warped incentives baked into the U.S.

Biosimilars 78

Biosimilars Production FDA Drugs 78

Drug Patent Watch

JUNE 17, 2024

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

Biosimilars 98

Biosimilars Pharmaceuticals 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promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.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

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

Biosimilars 40

Biosimilars Science FDA Production 40

Drug Channels

FEBRUARY 28, 2023

No promises about future articles. 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. See our forecast to the right.)

Biosimilars 72

Biosimilars Drugs 72

Drug Channels

JULY 27, 2021

Let’s cut through the summer haze with our refreshing breeze of articles and insights. In this issue: The top 10 stingiest hospitals Medicare Part B's savings from biosimilars What happened to hepatitis C drug costs and rebates? Costco beats Medicare Part D Plus, math madness with Duke’s Fuqua business school.

Biosimilars 52

Biosimilars Hospitals Drugs 52

Drug Channels

OCTOBER 27, 2021

It’s the biosimilar boom! drug spending shambles into the middle of the herd Plus, The Onion summons the only humorous article about CRISPR. PBMs are conjuring a terrifying number of formulary exclusions for oncology drugs Eerie! Brrr.did you hear that? Scream as Blue Cross Blue Shield frightfully overpays hospitals Shocking!

Biosimilars 75

Biosimilars Hospitals Independent Pharmacies Pharmacy 75

Agency IQ

OCTOBER 20, 2023

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. Fill out the form to read the full article.

Science 59

Science Biosimilars FDA Research 59

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

JULY 30, 2024

Go for a swim to cool off and then enjoy this refreshing selection of articles chosen by Drug Channels para tu. Did the FTC’s compelling interim report prove its case?

Biosimilars 40

Biosimilars Hospitals Drugs 40

Fierce BioTech

MARCH 28, 2024

Arshi Gupta's article underscores this, urging drug manufacturers to adopt integrated evidence strategies, medicalized engagement, and adaptability. Arshi Gupta's article underscores this, urging drug manufacturers to adopt integrated evidence strategies, medicalized engagement, and adaptability.

Biosimilars 52

Biosimilars Therapies Disease Drugs 52

Agency IQ

JULY 13, 2023

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). Fill out the form to read the full article.

Science 52

Science Biosimilars FDA Production 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

Biosimilars 40

Biosimilars FDA Production Treatment 40

Agency IQ

MARCH 1, 2024

Notably, he shared this information on his Twitter account, which was later scrubbed clean of his Tweets when Stephen Hahn took the helm of the agency, and is therefore no longer available ( see here for a Regulatory Focus article summarizing Gottlieb’s statements ). What are the impacts for regulated industry? The longest shutdown in U.S.

Government 40

Government FDA Biosimilars Regulations 40

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

JUNE 9, 2023

Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. The reduction from the current 10 years to either 9 or 5 years would allow earlier entry of generics and biosimilars. Generic and biosimilar developers benefit from earlier market entry.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

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

Agency IQ

MAY 3, 2024

Positive *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q2 2024.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Positive January 2023 Azacitidine Kabi (azacitidine)** Fresenius Kabi Deutschland GmbH Positive January 2023 Krazati (adagrasib) Mirati Therapeutics B.V.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

SEPTEMBER 22, 2023

Similarly, the agency simply notes that it would review potential biosimilar or interchangeable products consistent with its existing regulatory expectations for licensure. Going forward, the way that these labeling updates cause – or contribute to – product complexity is likely to be a key concern for generic and biosimilar developers.

FDA 40

FDA Biosimilars Production Drugs 40

Quanticate

SEPTEMBER 25, 2024

This article explores the application of ACR response criteria in clinical trials, focusing on the various response levels—ACR20, ACR50, and ACR70—and the methods used to analyse treatment responses over time.

Clinical Trials 91

Clinical Trials Trials Therapies Treatment 91

Agency IQ

MAY 31, 2024

Anticipated EC Decision Drug Company CHMP Opinion June 2024 Agilus (dantrolene sodium, hemiheptahydrate) Norgine Positive June 2024 Altuvoct (efanesoctocog alfa) Swedish Orphan Biovitrum AB Positive June 2024 Fruzaqla (fruquintinib) Takeda Pharmaceuticals Positive June 2024 Jeraygo (aprocitentan) Idorsia Pharmaceuticals Positive June 2024 Obgemsa (vibegron) (..)

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Regulations 117

Regulations FDA Production Disease 117

Drug Channels

SEPTEMBER 28, 2021

on international benchmarking goes viral Amazon is finally disrupting CVS—but not how you expected Plus, the best article ever about Elizabeth Holmes’s Theranos trial. P.S. Please join the more than 12,500 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

Hospitals 56

Hospitals Biosimilars Pharmacy Drugs 56

Agency IQ

AUGUST 2, 2024

Positive September 2024 Fymskina (ustekinumab)* Formycon AG Positive September 2024 Ituxredi (rituximab)* Reddy Holding GmbH Positive September 2024 Otulfi (ustekinumab)* Fresenius Kabi Deutschland GmbH Positive September 2024 Ranibizumab Midas (ranibizumab)* Midas Pharma GmbH Positive September 2024 Tuznue (trastuzumab)* Prestige Biopharma Belgium (..)

Regulations 40

Regulations Clinical Trials Production Trials 40

FDA Law Blog: Drug Discovery

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. As reported in this recent Pink Sheet article , FDA staff recently noted that a substantial majority of meeting requests for eligible in-person meeting types have not been requested as such.

FDA 59

FDA Biosimilars Production Drug Development 59

Agency IQ

OCTOBER 27, 2023

Webinar/ Seminar ( OPEN ) Coordinating Research and Evidence for Medical Devices (CORE-MD) 11/6/2023 11/7/2023 ENVI Committee Meetings in 2023 Committee Meeting ( OPEN ) European Parliament committee on the environment, public health and food safety (ENVI) 11/6/2023 11/8/2023 6th European Training Course on Quality Management for Blood Establishments (..)

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Drug Channels

JULY 29, 2020

Cool off by getting up close and personal with our refreshing selection of articles and insights. The steamy, socially distanced days of summer are here. P.S. Join the more than 9,700 followers of my curated links published on @DrugChannels on Twitter.

Pharmacy 52

Pharmacy Biosimilars Drugs Pharmaceuticals 52

Agency IQ

SEPTEMBER 15, 2023

Biosimilar applications under BsUFA, however, are set to decrease by 41.68% owing to an expected increase in the number of submitted applications). Read AgencyIQ analysis here.]

FDA 40

FDA Government Drugs Production 40

Agency IQ

JUNE 2, 2023

Given the number of approved drugs and biologics on the market that are dispensed on an outpatient basis – and their generic and biosimilar equivalents – the additional workload on FDA’s labeling review staff could be considerable.

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

JUNE 29, 2023

Finally, the agency plans to release new guidance pertaining to the labeling of interchangeable biosimilar biological products by September 30, 2023. Read our preview of FDA’s drug labeling and promotion activities here. ]

FDA 40

FDA Drugs Regulations Production 40

Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52

FDA Biosimilars Science Production 52