Express Pharma

NOVEMBER 1, 2024

Establishing Centers of Excellence and leveraging artificial intelligence for pharma research can advance India’s capabilities in NCEs, biologics, and biosimilars, placing it at the forefront of global pharma innovation. Enable global competitiveness The MedTech sector aspires to reduce import dependence and become globally competitive.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Biosimilars Communication Diabetes 105

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars 59

Biosimilars Labelling Communication 59

RX Note

DECEMBER 25, 2024

However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. Few years back, doctors are urged to prescribe drugs by active ingredients.

Biosimilars 52

Biosimilars Community Pharmacies Labelling Communication 52

Express Pharma

AUGUST 4, 2023

Stephanie Wasco joins as Head of Communications – Advanced Markets to lead Corporate and Marketing Communications and Product Branding in Advanced Markets such as the US and Europe. The post Biocon Biologics announces key leadership appointments appeared first on Express Pharma.

Communication 96

Communication Biosimilars 96

Pharmaceutical Technology

JUNE 15, 2023

Generic and biosimilar pharmaceutical company and Novartis subsidiary Sandoz announced its plan to accelerate patient access to biosimilars. In a 15 June statement, Sandoz said that it hoped the Act4Biosimilars action plan will provide actionable solutions to overcome barriers preventing patient access to biosimilars.

Biosimilars 52

Biosimilars Communication Pharmaceutical Companies Pharmaceutical Companies 52

Drug Patent Watch

JANUARY 7, 2025

When educating elderly patients: Be patient and take extra time to explain concepts Use larger print materials for easier reading Address concerns about changes in pill appearance or packaging Communicating with Young Adults Younger patients may be more open to generic drugs but might lack knowledge about how they work. ” FDA.gov, 2021.

Communication 69

Communication Dosage Drug Pricing Packaging 69

FDA Law Blog: Biosimilars

APRIL 1, 2025

A less robust schedule of external meetings and slower pace of publications of Guidance to Industry may further slow communication to sponsors who eagerly await information critical to inform their development programs.

Communication 77

Communication Drug Development 77

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.

Biosimilars 96

Biosimilars Communication Drug Development 96

Pharmaceutical Technology

JUNE 2, 2023

In a bit to challenge the market dominance of AbbVie’s Humira (adalimumab), the online pharmacy Cost Plus Drugs, owned by billionaire Mark Cuban has announced a plan to market Coherus Biosciences’ biosimilar Yusimry (adalimumab-aqvh), Cost Plus Drugs will be offering Yusimry at $569 per unit, excluding shipping and dispensing charges.

Biosimilars 52

Biosimilars Online Pharmacies Drug Pricing Communication 52

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.

Communication 111

Communication Documentation 111

Pharmafile

DECEMBER 23, 2022

Celltrion has announced that it has finalised its submission of a biologics license application for the subcutaneous version of a biosimilar to anti-inflammatory medicine Remicade, to be submitted to the FDA. read more.

Biosimilars 69

Biosimilars Communication 69

Pharma Marketing Network

MAY 22, 2025

Whether youre launching a blockbuster brand like Tirzepatide or navigating market access challenges for a biosimilar, your vendors expertise can directly impact your outcomes. Cultural Fit and Communication Is the vendor responsive? Smooth communication saves time, avoids rework, and builds trust across cross-functional teams.

Communication 52

Communication Biosimilars 52

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.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

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.

Communication 26

Communication Biosimilars 26

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.

Communication 105

Communication Dosage Biosimilars 105

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.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

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).

Labelling 64

Labelling Communication 64

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.

Communication 77

Communication Biosimilars Compounding 77

FDA Law Blog: Biosimilars

JUNE 18, 2025

If a company receives a voucher, it must meet certain requirements to qualify for expedited review: an applicant must submit the CMC portion of its application and draft labeling at least 60 days prior to the final application submission and be available for “ongoing communication with prompt responses to FDA inquiries.”

Communication 59

Communication Labelling Drug Development 59

Pharmaceutical Commerce

JUNE 17, 2025

Given the strict state and federal regulations governing how manufacturers communicate with or support patients, companies face significant legal and regulatory risk when managing PAP programs.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing Pharmaceutical Manufacturing 59

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.

Communication 53

Communication Documentation Biosimilars 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.

Biosimilars 52

Biosimilars Communication 52

FDA Law Blog: Biosimilars

APRIL 10, 2025

Under the law, FDA can redact or withhold information that falls under one of nine exemptions; the most commonly used exemptions are: information that describes FDAs internal deliberative processes (Exemption 2), information that is prohibited from disclosure by other laws (Exemption 3), confidential commercial or financial information or trade secrets (..)

Documentation 59

Documentation Packaging Communication 59

FDA Law Blog: Biosimilars

APRIL 13, 2025

While we dont always see eye-to-eye with OPDP reviewers when determining whether a communication is false or misleading, weve always appreciated that their perspective is grounded in FDAs mission to protect the public health.

Communication 52

Communication 52

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

Considerations include transparency regarding the data used to develop the change, comprehensive testing of the change, characterizing the performance of the device before and after the change, and plans in place for ongoing monitoring of device performance and communication of any unexpected changes in performance.

Labelling 115

Labelling Communication 115

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.

Medication Therapy Management (MTM) 52

Medication Therapy Management (MTM) Biosimilars Inpatient Communication 52

FDA Law Blog: Biosimilars

JUNE 5, 2025

On June 4, CDRH sent out an email stating that it would be updating the CDRH Portal to add new functionality to the SBD feature to allow communications between CDRH and industry in the portal rather than via email. This indicates that CDRH is still reviewing SBDs and looking for ways to facilitate communications.

Communication 52

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.

Biosimilars 52

Biosimilars Communication 52

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.

Communication 52

Communication Packaging Biosimilars Diabetes 52

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.

Controlled Substances 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

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.

Documentation 59

Documentation Communication 59

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.

Biosimilars 90

Biosimilars Communication 90

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.”

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

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.

Communication 59

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.

Communication 52

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.

Department of Veterans Affairs 52

Department of Veterans Affairs Communication Hospitals Biosimilars 52

Pharmaceutical Technology

DECEMBER 9, 2022

Instead, the focus remains on its domestic industry, particularly around biosimilars, while reducing reliance on imports and branded pharmaceuticals. While Brazil remains a high-growth market, investment in innovative pharmaceuticals is still limited. Please check your email to download the Whitepaper.

Drug Pricing 98

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars 98