pharmaphorum

OCTOBER 13, 2022

ResearchandMarkets also recently published a report , which highlighted only biosimilars as the emerging treatments for osteoporosis. Emerging research and biosimilars. Sandoz recently announced positive clinical trial results from a phase 1/3 into its biosimilar to denosumab.

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Biosimilars Communication Pharmaceutical Companies Pharmaceutical Companies 98

Express Pharma

MAY 24, 2023

The first day of the conference mainly consisted of portfolio management topics where industry leaders like Dr Mukesh Kumar, Edward Coutinho, Dr Paras Vasanani and Pradeep Patni covered issues related to biosimilars, pipeline management and collaborative partnering process to manage the planning perspectives and uncertainties efficiently.

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Biosimilars Communication Drug Development 96

FDA Law Blog: Biosimilars

JUNE 10, 2024

Below we highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. Communication Best Practices During a BIMO Inspection Provide timely and accurate responses to information requests.

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Communication Documentation 111

Big Molecule Watch

JANUARY 10, 2025

As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. Here are some of the top regulatory developments from 2024.

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Biosimilars Drug Pricing Labelling Communication 45

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

to help identify and address efforts to block or delay generic drug and biosimilar competition,” but, given FDA’s ministerial role in administering the Orange Book and FDA’s insistence that it will not review patents before they’re listed, it is unclear what FDA role will play. Similar requirements would apply to BLA sponsors.

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Communication Dosage Biosimilars 105

Pharmacy Times

DECEMBER 17, 2024

The tool is designed to address the nocebo effect, which was a concern of prescribers and other health care professionals.

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Communication Biosimilars 26

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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Biosimilars Community Pharmacies Medical Records Documentation 113

pharmaphorum

JULY 22, 2021

We found that strong and open channels of communication were imperative. We leveraged our ample experience in conducting global clinical trials in the field of monoclonal antibody biosimilar and designed the clinical trial for CT-P59 according to its mechanism of action of a monoclonal antibody to treat COVID-19 patients in early stages.”.

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Communication Packaging Biosimilars Pharmaceutical Companies 105

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Labelling Communication 64

FDA Law Blog: Biosimilars

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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Communication Vaccines Drug Development 59

Eye on FDA

FEBRUARY 10, 2021

Last month we looked at a review of FDA press releases for last year and as one might have expected, there was an enormous spike in communications as a result of the COVID-19 pandemic. Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture.

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Communication Biosimilars Compounding 77

FDA Law Blog: Biosimilars

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. Such changes are not limited to personal circumstances. The pandemic also deeply impacted how industry and the government conduct their operations.

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Communication Biosimilars Documentation 53

PharmaState Academy

JANUARY 23, 2024

The subsequent discussion on the transformation of the pharmaceutical marketing industry delved into the current market landscape for biologics and biosimilars, emphasizing patient-centric approaches and stakeholder confidence in the brand. The branding of an antibiotic in a jam-packed segment” by Md.

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Biosimilars Communication 52

Putting Patients First Blog

DECEMBER 9, 2024

Biosimilars and Generics The formulary inclusion of biosimilars and generics is essential in reducing the costs of medications for Medicare recipients. To enable lower cost medications, CMS would require that plan formularies prioritize access to biosimilars, generics, and affordable other alternatives.

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Medication Therapy Management (MTM) Biosimilars Inpatient Communication 52

Putting Patients First Blog

JULY 27, 2023

NHC Events Provide Connection and Content July 27, 2023 By: Bhriana Smith, Senior Coordinator, Communications The National Health Council (NHC) has brought diverse organizations together to forge consensus and drive patient-centered health policy for more than 100 years.

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Biosimilars Communication 52

pharmaphorum

FEBRUARY 26, 2021

The company has also faced claims that it did not adequately communicate the risks of its opioid painkillers in its marketing, contributing to the US’ ‘opioid epidemic’, and that its talc products could contain small amounts of asbestos and lead to cancer. Litigation & controversy.

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FDA Law Blog: Biosimilars

JULY 31, 2023

For an emergency oral prescription, the prescribing practitioner must communicate the information to the pharmacist during the oral communication. codified at 21 C.F.R. Patient Request A patient may also request that their prescription for a schedule II substance be partially filled.

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

Pharma Marketing Network

DECEMBER 4, 2024

Add to that the competition from generics and biosimilars, and the stakes couldn’t be higher. Tools like telehealth platforms, mobile apps, and digital detailing enable seamless communication with HCPs and patients. Why Digital Transformation is Essential Gone are the days when traditional marketing alone could suffice.

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FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.

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pharmaphorum

DECEMBER 9, 2022

To close, Ritchie compared the pharma example of the biosimilar filgrastim Zarzio, developed by Novartis Sandoz; its advert an exemplary exercise in asking the right questions. It’s not just about the first wave, Head said, but about communicating end-to-end through the entire process. A thought to grow green leaves, indeed.

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Biosimilars Communication 90

FDA Law Blog: Biosimilars

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] report certain device malfunctions, and.

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Labelling Communication Documentation 64

FDA Law Blog: Biosimilars

MARCH 7, 2024

As another example, both documents note the possibility that if FDA has safety information relevant to an ongoing study, it may request that the sponsor confirm that the DMC is aware of that safety data and is taking it into consideration, or “request that the sponsor arrange for FDA to communicate with, or even meet with, the DMC.”

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FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The conference is also beneficial for consultants in the areas of advertising, public relations, law, and marketing communications.

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Communication 59

PharmaState Academy

JULY 23, 2023

This knowledge will enable them to effectively communicate with doctors, patients and caregivers. It involves techniques that prioritize empathy, personalization, and delivering a human touch in marketing communications. To manage such conditions there will be dominance of biopharmaceutical products and biosimilars.

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Communication Diabetes Biosimilars Hospitals 52

PharmaState Academy

MAY 1, 2023

Communicate with patients and caregivers-at-home in a simple language Communicate with patients and caregivers-at-home in a very simple manner. which sells sophisticated products using simple communication. a pharmaco strong in biopharmaceuticals or biosimilars can work closely with banks. Do not be myopic.

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Department of Veterans Affairs Communication Hospitals Biosimilars 52

Big Molecule Watch

JUNE 4, 2024

The START program, led by the Center for Biologics Evaluation and Research (“CBER”) and Center for Drug Evaluation and Research (“CDER”), was designed to “help further accelerate the development of novel drug and biological products for treatment of rare diseases.”

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Documentation Communication Biosimilars 53

FDA Law Blog: Biosimilars

AUGUST 11, 2024

Even in a CFL world, these presentations likely fall short of the SASS standard where the communication “ relies on a study that is inadequate to support the representations or suggestions it presents [and] disclosure of the material limitations of that study does not correct the misleading message conveyed by the communication.”

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Labelling Communication 59

FDA Law Blog: Biosimilars

APRIL 30, 2024

The draft guidance attempted to clarify when a Sponsor’s question may be more appropriate for more informal communication. The PMA Day 100 meeting may be used to discuss clarifying questions about Major Deficiencies and preliminary approaches for a response.

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Communication 64

FDA Law Blog: Biosimilars

MAY 10, 2023

Second, the prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in CMS requirements for telemedicine services set forth at 42 C.F.R.

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Controlled Substances Communication 52

FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

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Documentation Packaging Communication Labelling 75

FDA Law Blog: Biosimilars

MARCH 21, 2024

Furthermore, as part of their internal communications about marketing practices, companies are advised that employees who review their own company’s products must disclose their employment.

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Packaging Communication 64

FDA Law Blog: Biosimilars

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD).

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Documentation Labelling Communication 105

Pharma Marketing Network

FEBRUARY 27, 2025

For example, a pharma company launching a new biosimilar for rheumatoid arthritis can publish a whitepaper detailing clinical comparisons with the branded biologic. This is where content marketing campaigns make a difference. Instead of traditional promotional tactics, pharma brands can use educational content to build credibility.

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Biosimilars Communication Diabetes Drug Development 52

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

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Controlled Substances Documentation Pharmaceutical Manufacturing Communication 45

FDA Law Blog: Biosimilars

JANUARY 22, 2024

Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year.

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Compounding Online Pharmacies Communication 59

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. Instead, maintain face-to-face communication around the time of LOE – when generic competitors enter the market it can be really valuable way to maintain already loyal customers. The branded version still has the company perspective and the relational perspective.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

To stay up to date with changes or review ones that have been implemented, refer to the regular communications, which can be found here. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

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Packaging Communication 59