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labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.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

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The Pharma Data

APRIL 18, 2022

. “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines,” said David M. Amgen has a total of 11 biosimilars in its portfolio, including five that have been approved by the U.S. Reese, M.D., executive vice president of Research and Development at Amgen.

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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.

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Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

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Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! We also update sections that were introduced in recent editions, such as our estimates of wholesalers' profits from provider-administered biosimilar drugs.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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Licensing Licensing Pharmacy Regulations 45

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.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

As to biosimilars, FDORA amends the statutory language regarding criteria for the demonstration of biosimilarity for a 351(k) biologic. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).

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The Pharma Data

JUNE 7, 2022

Nasdaq: BIIB) — Biogen and Alectos Therapeutics have entered into a license and collaboration agreement to develop and commercialize a novel preclinical selective GBA2 inhibitor, AL01811, which has first-in-class potential as an oral disease modifying treatment for patients with Parkinson’s disease (PD). Biogen Inc.

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Licensing Licensing Small Molecule Disease 40

The Pharma Data

MARCH 5, 2021

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Source link:[link].

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FDA Law Blog: Biosimilars

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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Drug Channels

FEBRUARY 21, 2023

If you have any questions before purchasing a license to the report, please email me. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow. Click to Enlarge] Thank you for your interest in our work. Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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The Pharma Data

OCTOBER 18, 2021

under a cooperative development and license agreement. Tofersen is also being studied in the Phase 3 ATLAS study, which is designed to estimate the capability of tofersen to delay clinical onset when initiated in presymptomatic individualities with a SOD1 inheritable mutation and biomarker substantiation of complaint exertion.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

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Drug Channels

SEPTEMBER 12, 2023

The notable new material in this 2023-24 edition includes new data about commercial pricing and reimbursement for provider-administered biosimilars as well as updated, expanded, and reorganized data about pharmacy services administrative organizations and group purchasing organizations for small pharmacies and physician practices.

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Drug Channels

SEPTEMBER 17, 2024

Review pricing/license options and place a preorder Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits) You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal.

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Pharmaceuticals Licensing Licensing Drugs 52

FDA Law Blog: Biosimilars

JANUARY 11, 2024

Some of the other (but not all…) topics of interest at this day-long conference presented by US and Puerto Rico industry thought leaders include: Experiences and Challenges of Puerto Rico State Licensing Internal Investigations: Monitoring, Compliance, Enforcement Actions The State of the Pharmaceutical Industry in Puerto Rico Navigating Global Turbulence: (..)

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Pharmaceuticals Licensing Licensing Compliance 59

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

Specifically, FDC Act 201(ff)(3)(B) provides that a dietary supplement does not include: (i) an article that is approved as a new drug under section 355 of [the FDC Act], certified as an antibiotic under section 357 of [the FDC Act], or licensed as a biologic under section 262 of title 42, and (ii) an article authorized for investigation as a new drug, (..)

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Production FDA Licensing Licensing 59

FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners.

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The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. Teva Pharmaceutical Industries Ltd.

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FDA Law Blog: Biosimilars

JULY 18, 2023

Those include biological products licensed under Biologics License Applications (BLAs), approved drugs under New Drug Applications (NDAs), and generic products under approved Abbreviated New Drug Applications (ANDAs). That leaves 60% that manufacture at least one application product.

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FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

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The Pharma Data

JANUARY 24, 2021

The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases.

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Agency IQ

SEPTEMBER 22, 2023

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) – and includes prescribing information (PI).

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. The content and prescription information elements required by 21 C.F.R. cannot be altered during the transmission. to be codified at 21 C.F.R. to be codified at 21 C.F.R.

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Pharmacy Regulations Licensing Licensing 52

FDA Law Blog: Biosimilars

JUNE 17, 2024

Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA). The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog.

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Pharmaceuticals FDA Production Drugs 59

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

. § 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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The Pharma Data

JULY 27, 2021

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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The Pharma Data

SEPTEMBER 16, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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