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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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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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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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Read on for this week’s.

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Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! The exhibits appear in all license versions. The PowerPoint file option is available only with the purchase of a corporate license.)

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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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Drug Channels

FEBRUARY 22, 2022

We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars. If you have any questions before purchasing a license to the report, please email me. Download a free report overview for more details. The chart below illustrates the depth and breadth of the 2022 edition. Click to Enlarge].

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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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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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Drug Discovery World

MAY 1, 2023

The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified. It also suggested that it is unfeasible to expect small and mid-sized companies to launch their product in all 27 Member States in a given time frame.

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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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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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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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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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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.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). If the drug were legally marketed, the considerations may be different, and therefore CVM recommends that these sponsors “obtain an index listing, approval, or conditional approval.”

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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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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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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

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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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 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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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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Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . The restriction will apply for two years. . EMA Report. .

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FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. However, an exclusive license is not an authorization to rely on the activities of the marketing applicant for a PTE application. and OPKO Ireland Ltd.

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Agency IQ

JUNE 2, 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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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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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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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

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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

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s. Since October 2017 Biogen and Eisai Co.,

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FDA Law Blog: Biosimilars

JUNE 27, 2024

It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id. The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. at § 64B16-27.800(2).

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