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labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

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

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.

Biosimilars 59

Biosimilars FDA Production Marketing 59

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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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

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.,

FDA 59

FDA Biosimilars Production Regulations 59

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.

Licensing 45

Licensing Licensing Pharmacy Regulations 45

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement.

Production 59

Production FDA Licensing Licensing 59

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

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

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). 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

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.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

FDA 52

FDA Biosimilars Science Drugs 52

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.

FDA 111

FDA Regulations Treatment Licensing 111

DrugBank

OCTOBER 4, 2024

These structures are particularly relevant in dealing with uncertainty about the future commercial potential of the target's products. 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.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

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. In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums.

Laboratories 81

Laboratories FDA Regulations Licensing 81

DrugBank

DECEMBER 4, 2024

Estimates suggest that LMIC loses billions of dollars annually due to productivity losses and healthcare costs associated with preventable and treatable diseases, creating a positive feedback loop that increases poverty.   The economic toll of untreated diseases is also substantial.

Drugs 52

Drugs Licensing Licensing Pharmaceutical Companies 52

Drug Target Review

JULY 6, 2023

3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.”

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs 59

Drugs FDA Licensing Licensing 59

The Pharma Data

OCTOBER 18, 2021

Tofersen binds to SOD1 mRNA, allowing for its declination by RNase-H in an trouble to reduce conflation of SOD1 protein product. under a cooperative development and license agreement. About Tofersen Tofersen is an antisense medicine being estimated for the implicit treatment of SOD1-ALS.

Biosimilars 40

Biosimilars Protein Production Licensing Licensing 40

FDA Law Blog: Biosimilars

JULY 18, 2023

Forty percent of those sites are in what CDER terms the “No Application” sector, meaning that those sites make over the counter (OTC) products, unapproved drugs, and homeopathic products, all sold without premarket approvals. That leaves 60% that manufacture at least one application product.

FDA 52

FDA Licensing Licensing Laboratories 52

The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. NYSE and TASE: TEVA), have reached an agreement with Lupin to resolve the dispute over Lupin’s Abbreviated New Drug Application (“ANDA”) for a generic deutetrabenazine product. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd.

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

Biosimilars 40

Biosimilars FDA Production Treatment 40

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.”. . Those measures are due to expire on 1 December. DKMA Guidance. . EMA Report. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 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). Other notes from the report include: FDA keeps a vast catalog of drug products. That total—148,886 listed products—is a 6% increase over FY2022.

Pharmaceuticals 59

Pharmaceuticals FDA Production Drugs 59

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

FDA 59

FDA Production Marketing Drugs 59

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. Section II at 2. Draft Guidance III.B.2(e)

FDA 52

FDA FDA Approval Licensing Licensing 52

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). Product Sales Performance. driven by the write-off of $1.5

Biosimilars 52

Biosimilars Production Treatment FDA 52

The Pharma Data

JULY 27, 2021

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Production 52

Production Clinical Trials Government Disease 52

Agency IQ

SEPTEMBER 22, 2023

According to that document, PDURS are “software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products.” patient, caregiver) in the use of their medications (including both pharmaceuticals and biological products) would be considered PDURS.

FDA 40

FDA Biosimilars Production Drugs 40

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab).

FDA 59

FDA Production FDA Approval Licensing 59

The Pharma Data

SEPTEMBER 16, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

SEPTEMBER 20, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Clinical Trials 52

Clinical Trials Production Trials Government 52

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 9, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

Trials 52

Trials Production Clinical Trials Government 52

Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

Title Type Date Received by OIRA Legal Deadline Expedited Program for Serious Conditions –Accelerated Approval of Drugs and Biologics Draft Guidance July 9 Yes Conducting Clinical Trials With Decentralized Elements Draft Guidance July 25 Yes Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft (..)

FDA 40

FDA Science Regulations Biosimilars 40

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.

Disease 40

Disease FDA Clinical Trials Licensing 40