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

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

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The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public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The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public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

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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Biosimilars Documentation 45

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 million people have type 1 diabetes in the U.S., Type 1 affects 8% of everyone with diabetes.

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Diabetes Biosimilars Documentation Compounding 246

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

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

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Practising QbD in biosimilar product development. For biosimilars, however, this process is slightly more complex.

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Biosimilars Vaccines Drug Development Documentation 52

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

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

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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Biosimilars Documentation Pharmaceutical Companies Pharmaceutical Companies 79

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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Controlled Substances Documentation Dosage Prescription Filling 139

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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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

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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Biosimilars Labelling Documentation 98

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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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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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

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 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

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B.

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Documentation Labelling Communication 105

Express Pharma

JUNE 28, 2024

The day concluded with insights into future data and documentation imperatives, highlighting meticulous record-keeping and data management for compliance and quality. Day 2 began with opening remarks from Sarah McMullen, Country Director, USFDA.

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Biosimilars Documentation 108

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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Documentation 119

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject.

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pharmaphorum

APRIL 16, 2021

NICE noted in its guidance document that “patient experts explained that the fortnightly infusions make it difficult for people to work, socialise and join in with family life.” Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for an eight-week dosing schedule after a loading phase.

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Biosimilars Documentation 52

FDA Law Blog: Biosimilars

JUNE 10, 2024

Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. Provide a method of verifying or monitoring the effectiveness of the actions. training, standard operating procedure (SOPs), corrective action plans, records, etc.).

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Communication Documentation 111

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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Documentation 105

FDA Law Blog: Biosimilars

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

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Documentation 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

Upcoming biosimilar competition for Humira means AbbVie’s focus may turn to Rinvoq, approved in the US for atopic dermatitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, and Skyrizi, approved in the US for psoriatic arthritis and plaque psoriasis. Bristol Myers Squibb (BMS) documented a 9.1%

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Vaccines Drug Pricing Biosimilars Documentation 108

FDA Law Blog: Biosimilars

MARCH 7, 2023

Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission. This may result in the need to create additional documents that you may not necessarily need under the quality system.

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Documentation Communication 59