Biosimilars, Definition, Licensing and Regulations

FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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

Biosimilars Production FDA Licensing

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.”

FDA

FDA Biosimilars Production Regulations

Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. The 2022 Economic Report on U.S. Click to Enlarge].

Pharmacy

Pharmacy Specialty Pharmacies Biosimilars Licensing

The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. What led to NPA’s lawsuit? The facts are detailed in the complaint.

Production

Production FDA Licensing Licensing

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. The 2023 Economic Report on U.S.

Pharmacy

Pharmacy Specialty Pharmacies Licensing Licensing

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Agency IQ

SEPTEMBER 22, 2023

The FDA regulates both product labeling ( 21 CFR 201 ) and promotional labeling ( 21 CFR 202 ). FDA anticipated at the time that most PDURS output would be promotional labeling, and therefore “would only be required to be submitted at the time of initial dissemination, pursuant to these existing regulations.”

FDA

FDA Biosimilars Production Regulations

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

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

Biosimilars Science FDA Licensing

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Laboratories

Laboratories FDA Regulations Licensing

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Drugs

Drugs Regulations Government Vaccine

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. Marijuana” outside of the CSA definition, including hemp, mature stalks, fiber from the mature stalks, oil or cake made from seeds, and sterilized seeds incapable of germination are not controlled and not subject to the recommendation.

FDA

FDA FDA Approval Treatment Drugs

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority B List.

FDA

FDA Science Biosimilars Production

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g.,

Compliance

Compliance Pharmacy Drugs Licensing

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

FDA

FDA FDA Approval Production Regulations

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. J Intern Med 2012;272:121–32.

Trials

Trials Production Clinical Trials Government

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 2019;12(5):539-549. Eur Respir J.

Trials

Trials Production Clinical Trials Government

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

OASH concluded “there is widespread current experience with medical use of marijuana in the United States” by licensed healthcare providers “operating in accordance with implemented state-authorized programs, where such medical use is recognized by entities that regulate the practice of medicine under these state jurisdictions.”

Regulations

Regulations FDA Licensing Licensing

Drug Discovery Digest

FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

FDA Knows Its Own Strength—and It Includes Concentration

Trending Sources

Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Stay Connected