Biosimilars, Pharmacokinetics and Production

FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS?

The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”

FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

FDA

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

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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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

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

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Accelerating Global Drug Development Timelines With Ethnobridging

Alta Sciences

JUNE 9, 2023

Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money.

Drug Development

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Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

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

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. Due to concerns over manufacturing consistency and stability, the FDA required all oral levothyroxine manufacturers to obtain NDAs to continue marketing their products lawfully.

FDA

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

Agency IQ

FEBRUARY 12, 2024

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, CDER, CDRH, CFSAN), as well as some additional FDA offices (like its Office of the Chief Scientist ). This list is known as the FDA’s “guidance agenda.”

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

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

FDA

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FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

“Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

FDA

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

The Pharma Data

NOVEMBER 6, 2020

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. The safety and tolerability of aducanumab was the primary aim of the study. About Alzheimer’s Disease.

Disease

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Can Your CRO Add Value During a Recession?

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics.

Clinical Trials

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PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. Food and Drug Administration (FDA). About Pfizer Oncology.

Clinical Trials

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. Basis at 18; NPRM at 44,605. Basis at 24. Basis at 63-64.

Regulations

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Drug Discovery Digest

FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS?

FDA Releases Draft Guidance on Essential Drug Delivery Outputs

Webinars

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Webinars

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Accelerating Global Drug Development Timelines With Ethnobridging

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

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

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

FDA Action Alert: MacroGenics and Amgen

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

Can Your CRO Add Value During a Recession?

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

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