2024, Biosimilars and Communication

FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

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.

FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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

Biosimilars Labelling Communication

Highlights from Day 6 of World Pharma Brand Managers Week

PharmaState Academy

JANUARY 23, 2024

In a significant convergence of over 900 industry professionals spanning six days during the World Pharma Brand Managers Week 2024, the joint event was organized by PharmaState.Academy and IES’s Management College and Research Centre (IESMCRC) , emerged as a pivotal platform. The branding of an antibiotic in a jam-packed segment” by Md.

Biosimilars

Biosimilars Communication

Eminence Business Media hosts sixth edition of Annual Pharma Project & Portfolio Management 2023

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.

FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction

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The draft guidance attempted to clarify when a Sponsor’s question may be more appropriate for more informal communication. This draft guidance is open for comments through May 14, 2024, which can be submitted online.

Communication

May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

FDA Law Blog: Biosimilars

MAY 10, 2023

In addition, concerning any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, all telemedicine flexibilities concerning prescribing of controlled substances established during the COVID-19 PHE will also be extended for one year – through November 11, 2024. 1307.41and 42 C.F.R.

Controlled Substances

Controlled Substances Communication

Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

FDA Law Blog: Biosimilars

DECEMBER 7, 2023

He also noted that the VSD “does not supplant existing obligations to report to appropriate regulatory agencies, nor is it intended to alter those existing practices and channels of communication.” As that may develop, the 2024 edition of this conference will be worth coming back for.

Communication

Bad Labs! Bad Labs? Whatcha Gonna Do?

FDA Law Blog: Biosimilars

MARCH 11, 2024

Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Allyson B.

Communication

Minor Updates to FDA Pre-Submission Guidance With More to Come

FDA Law Blog: Biosimilars

JUNE 20, 2023

Draft Guidance Finally, as part of MDUFA V , FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024. In doing so, we hope FDA will adopt an open mind when it comes to expanding the topics on which it will consider providing informal feedback.

Documentation

Documentation Communication

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. CDER shortages and CBER shortages ).

Communication

It’s the Law Now –Cybersecurity Information in Premarket Submissions

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. Per section 3305(e) of the Omnibus, FDA must provide an updated guidance document by December 2024. We look forward to it.

Documentation

Documentation Labelling Communication

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog: Biosimilars

JUNE 14, 2023

In FY 2024, continue to support products enrolled in the previous fiscal year and expand to enroll up to 45 additional products in at least two OHTs (i.e., up to 60 total products enrolled through FY 2024). One mechanism to incorporate payors’ voices is through the Payor Communication Task Force.

Communication

PharmaShots' Key Highlights of First Quarter 2023

PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments. The authorization incl.

Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

Sandoz targets barriers to biosimilar accessibility with latest initiative

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.

Inflationary storm clouds will continue to buffet global pharma industry in 2023

Pharmaceutical Technology

JANUARY 16, 2023

Negotiations over these products are expected from October 2023 and run until August 2024. However, low-cost generic and biosimilar manufacturers are likely to be particularly exposed to these economic pressures. The entire pharma industry will be affected by the fallout. Free Report. Please check your email to download the Report.

Drug Pricing

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Inflationary storm clouds will continue to buffet global pharma industry in 2023

Pharmaceutical Technology

JANUARY 16, 2023

Negotiations over these products are expected from October 2023 and run until August 2024. However, low-cost generic and biosimilar manufacturers are likely to be particularly exposed to these economic pressures. The entire pharma industry will be affected by the fallout. Free Report. Please check your email to download the Report.

Drug Pricing

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies Biosimilars

Pharmacist Digest

FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

Trending Sources

Highlights from Day 6 of World Pharma Brand Managers Week

Eminence Business Media hosts sixth edition of Annual Pharma Project & Portfolio Management 2023

FDA’s Draft Guidance on the Q-Submission Program – A Step in the Wrong Direction

May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

Bad Labs! Bad Labs? Whatcha Gonna Do?

Minor Updates to FDA Pre-Submission Guidance With More to Come

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

It’s the Law Now –Cybersecurity Information in Premarket Submissions

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

PharmaShots' Key Highlights of First Quarter 2023

Humira biosimilars set the stage for long-awaited 2023 US launches

Sandoz targets barriers to biosimilar accessibility with latest initiative

Inflationary storm clouds will continue to buffet global pharma industry in 2023

Inflationary storm clouds will continue to buffet global pharma industry in 2023

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