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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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 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 98

Biosimilars Pharmacy Drugs Marketing 98

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 110

Biosimilars Pharmaceuticals Marketing 110

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.

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Biosimilars Production FDA Drugs 98

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 97

Biosimilars Drugs 97

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 97

Biosimilars Hospitals Independent Pharmacies Pharmacy 97

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 98

Specialty Pharmacies Pharmacy Biosimilars Drugs 98

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

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

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

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

Drug Discovery World

AUGUST 29, 2022

He has over 12 years of experience in the healthcare sector and is the author of over 30 peer-reviewed scientific articles. How can automation push the development of biologics and biosimilars? . Dr Anvar was a senior scientist before joining OKRA, serving as the principal investigator of preclinical personalised medicine.

Bioinformatics 130

Bioinformatics Biosimilars Drugs Science 130

Drug Discovery World

SEPTEMBER 23, 2022

How can automation help the discovery of biologics and biosimilars? here, covers the themes of the event – Driving the Next Life Science Revolution – as well as details on the new Tech Theatre, supported by DDW, which will feature a series of seminars focused on automation and technology for drug discovery.

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Biosimilars Drugs Laboratories Science 130

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

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

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

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 Compliance 40

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 81

Hospitals Biosimilars Pharmacy International 81

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

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 Biosimilars Clinical Trials 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

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 International 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 Regulations 40

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 119

Regulations FDA Production Disease 119

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.

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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

JUNE 5, 2023

Sponsored guest posts are bylined articles that are screened by Drug Channels to ensure a topical relevance to our exclusive audience. Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply.

Specialty Pharmacies 74

Specialty Pharmacies Pharmacy Biosimilars Compliance 74

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

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

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 Licensing 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 Biosimilars 40

Drug Discovery World

OCTOBER 3, 2022

He has over 12 years of experience in the healthcare sector and is the author of over 30 peer- reviewed scientific articles. Also on that day the Tech Theatre will run a presentation on How automation can push the discovery of biologics and biosimilars?

Laboratories 130

Laboratories Drugs Science Small Molecule 130

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

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Pursuant to FSMA, FDA amended the requirements for prior notice of imported food, to include a requirement to report the name of any country to which the article has been refused entry. The proposed rule also establishes a timeframe by which food articles subject to refusals or holds must become compliant.

Regulations 52

Regulations FDA Compliance International 52

Vial

APRIL 10, 2024

This article provides a comparative overview of Vial and IQVIA. With over 1,100 CROs worldwide as of 2020, choosing the appropriate partner often requires evaluating the advantages and disadvantages of large global CROs versus mid/small ones. A Brief Introduction Founded in 1982, IQVIA has emerged as one of the largest CROs in the world.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52