FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

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Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

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Agency IQ

NOVEMBER 3, 2023

In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

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Agency IQ

JANUARY 19, 2024

approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S. FDA in October 2023. The product was approved in the E.U. However, BeiGene announced that it is seeking approval in the U.S. Based on the E.U.

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The Pharma Data

OCTOBER 27, 2020

RPD designation is granted by the FDA to encourage treatments for serious or life-threatening diseases primarily affecting children 18 years of age and younger and fewer than 200,000 people in the United States.

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Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada.

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The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

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Agency IQ

APRIL 26, 2024

The FDA published recommendations for interchangeable products separately in a completely new guidance , issued two years later. According to the document, the agency no longer recommends the use of the term “interchangeable” in any portion of the labeling, nor does it provide a definition for this term. Yes, the guidance confirms.

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Agency IQ

MAY 31, 2024

Unpacking FDA’s long-awaited platform technology designation program and guidance Months overdue, the FDA’s Platform Technologies Designation guidance document has just been published by the agency. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors.

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Codon

JULY 14, 2024

From Early Transfusion to Component Therapy The earliest documented attempts at blood transfusions involved the transfer of blood from animals to humans in the 17 th century. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. Subscribe to Asimov Press.

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Agency IQ

JANUARY 26, 2024

To support industry’s accurate identification and updating of drug expiration dates, the FDA has released a handful of guidance documents for industry. Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients.

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The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

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The Pharma Data

DECEMBER 31, 2020

–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced that the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies remains under review by the U.S. 1, 2021 11:59 UTC.

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Agency IQ

SEPTEMBER 29, 2023

AgencyIQ / FDA October 1 PAHPA Authorization lapses Unless reauthorized by Congress – and at this point, it’s looking unlikely – programs operating under the authority of the Pandemic and All-Hazards Preparedness Act and requiring reauthorization will cease to exist as of the start of the fiscal year. This is what OIRA is currently reviewing.

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Agency IQ

OCTOBER 27, 2023

What we expect to be talking about in November and December: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. Government shutdown: At present, the U.S.

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Agency IQ

DECEMBER 1, 2023

What we expect to be talking about in December and January: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. This is what OIRA is currently reviewing.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. Some of the affected former NDAs were approved using drug master files (DMFs).

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Agency IQ

JUNE 2, 2023

The PMI itself would be a one-page document that would include a standardized format and content, and would be subject to FDA review and approval. Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. The format of the PMI : At just one page (8.5×11

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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The Pharma Data

DECEMBER 15, 2020

Scientists documented a significant depletion of long-lived plasma cells, a reduction of interferon type I activity, and a down-regulation of T-cell transcripts associated with chronic inflammation. The patients’ symptoms included inflammation of the heart and kidneys and antibody-induced anemia.

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The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

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Drug Discovery World

FEBRUARY 22, 2024

The FDA has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) injection, for reducing the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD).

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Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. See 2023 Mich.

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