Safe Biologics

APRIL 30, 2024

From ASBM’s comments: We believe that clinical data, including comparative effectiveness studies (CES), have played a critical role in building physician and patient confidence in biosimilars and should continue to be required for complex biosimilars such as monoclonal antibodies.

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STAT

OCTOBER 23, 2024

Amgen will launch its biosimilar version of a blockbuster Regeneron Pharmaceutical drug for an eye disease following a U.S. The FDA still has to make a decision on whether to officially place semaglutide on the lists. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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Compounding Compounding Pharmacies Documentation Biosimilars 251

PharmaTech

JULY 25, 2024

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

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Biosimilars Documentation 52

Big Molecule Watch

MAY 25, 2023

As we have previously reported , Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. As we have previously reported , and as Amgen’s supporting brief confirms, Amgen is developing its own biosimilar candidate to Eylea known as “ABP 938.” common law.

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Documentation Biosimilars 64

Express Pharma

MARCH 16, 2025

To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

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FDA Law Blog: Biosimilars

JULY 29, 2024

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.

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Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

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Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Labelling Biosimilars Documentation 52

PharmaTech

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Labelling Biosimilars Documentation 52

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Big Molecule Watch

AUGUST 20, 2024

On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”). For the time being, the FDA asks two questions.

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FDA Law Blog: Biosimilars

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. See 21 C.F.R. For example, in an October 13, 2023 WL to ReNovo, Inc.,

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Documentation 64

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

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Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin.

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Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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Biosimilars Communication Labelling Documentation 49

Safe Biologics

MAY 21, 2024

Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a r esponse published in GaBI Journal. Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such.

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Biosimilars Documentation 100

Big Molecule Watch

NOVEMBER 18, 2024

related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. The post Amgen Files BPCIA Complaint Against Accord Biopharma Regarding Denosumab Biosimilar appeared first on Big Molecule Watch. Accord Healthcare, Inc.; and Intas Pharmaceuticals, Ltd.,

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Biosimilars Documentation 49

FDA Law Blog: Biosimilars

APRIL 10, 2025

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.

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Documentation Packaging Communication 59

Big Molecule Watch

APRIL 18, 2023

As we previously reported , Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The post Regeneron v.

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Documentation Biosimilars 75

FDA Law Blog: Biosimilars

DECEMBER 15, 2024

In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. In fact, nearly all of the CMC comments are directing us to existing guidance documents. The guidance documents that CBER has issued in recent years in the CGT space have been important steps forward.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.

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Documentation Packaging Clinical Pharmacology Drug Development 59

Pharma Pathway

SEPTEMBER 22, 2022

Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Please Bring the following copies of below documents along with Originals: SSC & Intermediate Certificated & Marks Sheet. Job Role : Apprentice -Trainee.

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Big Molecule Watch

JUNE 13, 2025

The opinion arises in the context of ongoing patent litigation in South Korea between Amgen and Celltrion regarding Celltrion’s denosumab biosimilar. . § 1782, but has not yet conclusively defined the scope of that discovery, the decision is not “final” and thus may not be appealed under 28 U.S.C. Section 1782 allows U.S.

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Documentation Biosimilars 59

FDA Law Blog: Biosimilars

JUNE 25, 2024

Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. But, as time has marched on and FDA’s experience with interchangeable biosimilars grown, the Agency’s “experience has shown that.

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Biosimilars Documentation 52

European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

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Drug Development Documentation Biosimilars 105

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution. The order also enjoins the pharmacist-owner from serving as a PIC at any other pharmacy for seven years. Consent Agreement and Final Judgment ¶ 17.

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pharmaphorum

NOVEMBER 13, 2020

NICE’s final appraisal document notes that patients receiving the dual regimen “live longer and have longer before their disease progresses than people who have sorafenib” and it is a cost-effective use of NHS resources. Sales of Tecentriq sales rose 64% to around $2.2 Cablivi gets green light for aTTP.

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Documentation Biosimilars 105

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Document dumps,” he said, are not helpful without the assistance of a narrative placing the documents in context.

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Documentation 97

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Biosimilars are key to making healthcare more affordable and accessible. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

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Biosimilars Documentation 52

Big Molecule Watch

OCTOBER 14, 2024

On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA.

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Biosimilars Documentation 64

pharmaphorum

SEPTEMBER 16, 2021

Promoting automatic substitution of, for example, biosimilars on formularies and registers could accelerate conversion to use of biosimilars, releasing significant financial savings. But in some areas of prescribing national leadership is needed to accelerate and support local systems’ medicines optimisation efforts.

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European Pharmaceutical Review

DECEMBER 20, 2023

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). What are the latest amendments?

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different. RIEs will require the facility to accommodate the “use of teleconference, livestream video, and screen sharing of data and documents.” We should explain what RIEs are.

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Documentation Medical Records 105

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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Documentation Adverse Reactions Communication Drug Development 105

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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Biosimilars Pharmaceutical Manufacturing Hospitals Documentation 75

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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Biosimilars Hospitals Pharmaceutical Manufacturing Documentation 74