2019, Biosimilars and Labelling

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. Leading FDAs policy implementation of the MODERN Labeling Act , the statutory authority allowing FDA to make certain generic drug labeling updates. 314.150(c).

Documentation

Documentation Labelling Drug Development

New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

JUNE 27, 2025

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. November 21, 2019. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring. 2024;22(4):22-29.

Pharmacy Technician

Pharmacy Technician Diabetes Compounding Pharmacies Pharmacy Management

Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

JULY 1, 2025

The last time we spoke, biosimilars were this new thing and everyone was trying to figure out what was going to happen regulatory-wise and a lot of other changes since then. So, we would have spoken in 2019. So, good talking to you. Matt Paterini (01:21): No, we appreciate the time. And remember, COVID was in there too, right?

Hospitals

Hospitals Packaging Documentation Labelling

Pharmacists Have a Crucial Role Helping Patients With ATTR-CM Navigate Treatment With Tafamidis

Pharmacy Times

JULY 1, 2025

1,2 Tafamidis in the Treatment of ATTR-CM Initially approved in 2019 3 , tafamidis (Vyndamax; Pfizer) is a selective transthyretin (TTR) kinetic stabilizer that binds to thyroxine-binding sites on TTR tetramers, which prevents dissociation into monomers, or the breakdown into amyloid deposits that damage the heart in ATTR-CM. May 6, 2019.

HIV Treatment and Prevention Agents

HIV Treatment and Prevention Agents Pharmacy Technician Insurance Coverage and Processing Specialty Pharmacies

Gabapentin Use Linked to Increased Dementia Risk in Chronic Back Pain Patients

Pharmacy Times

JULY 17, 2025

1 Image Credit: Syahrir | stock.adobe.com Gabapentin is FDA approved for partial seizures and postherpetic neuralgia, but has widespread off-label use for various chronic pain conditions, including back pain. Published December 2019. Subscribe Now!

Pharmacy Technician

Pharmacy Technician Compounding Pharmacies Pharmacy Management Immunity

Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

JUNE 20, 2025

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. December 12, 2019. Oncology pharmacy practice changes at a rapid pace. How your oncology peers manage the complexities of care.

Pharmacy Technician

Pharmacy Technician Compounding Compounding Pharmacies Biosimilars

To Combat Medication Errors, Proper Pharmacy Inventory Counts Are Essential

Pharmacy Times

JUNE 5, 2025

Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. 4 Detect-A-Dose features a contrasting black and white pattern on the underside of its label to make missing doses for patients apparent to pharmacists.

Pharmacy Technician

Pharmacy Technician Packaging Labelling Compounding Pharmacies

J&J eyes prostate cancer label expansion for Akeega

Pharmaceutical Technology

JULY 7, 2025

The hormone therapy, approved in 2019, is forecast to see annual sales of $5.3bn by 2031. Robert Barrie July 7, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The application comes hot on the heels of positive data for Akeega unveiled at this year’s American Society of Clinical Oncology (ASCO) conference.

Labelling

Labelling Packaging Communication Hospitals

From data to impact: How real-world evidence will transform healthcare

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Pharmaceutical Companies Pharmaceutical Companies

Smarter learning and better outcomes: How AI can provide an advantage in medical education

pharmaphorum

AUGUST 14, 2025

Skip to main content Thursday 14 August 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views (..)

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Labelling

Why security-first design is the fix to stalling AI pilot tools

pharmaphorum

JULY 2, 2025

Skip to main content Wednesday 2 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Drug Development

To 513(g) or not to 513(g)? That is the question

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

Documentation

Documentation Labelling

J&J bids to extend prostate cancer uses for Akeega

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Diabetes

Diabetes Pharmaceutical Companies Pharmaceutical Companies Labelling

Moderna shines spotlight on new flu vaccine data

pharmaphorum

JUNE 30, 2025

Skip to main content Monday 30 June 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Vaccines

Vaccines Diabetes Pharmaceutical Companies Pharmaceutical Companies

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

Biosimilars

Biosimilars Labelling Diabetes

May 2024 Newsletter

Safe Biologics

JUNE 6, 2024

Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies. View the resource guide here.

Biosimilars

Biosimilars Labelling

Boost for AZ as Ultomiris gets CHMP nod for expanded label

pharmaphorum

JULY 26, 2021

Fresh from its takeover of Alexion, AstraZeneca has picked up a recommendation in the EU for an expansion of the label of Ultomiris, one of the main assets behind the $39 billion merger. The post Boost for AZ as Ultomiris gets CHMP nod for expanded label appeared first on.

Labelling

Labelling Biosimilars

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

Moving towards oral delivery of biologics

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. 2019 [cited 2023Feb]. Oral delivery of biologics via the intestine.

Dermavant claims its first approval as FDA clears psoriasis drug

pharmaphorum

MAY 25, 2022

Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) and has been approved by the US regulator with a broad label spanning mild, moderate, and severe psoriasis and an unlimited duration of use. Otezla – which Amgen acquired for $13.4

Labelling

Labelling Biosimilars

PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

FDA Law Blog: Biosimilars

JUNE 11, 2023

However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. Still, however, it appears FDA has had enough of these 16%.

Labelling

Labelling Drug Development

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

Drug Development

Drug Development Documentation Labelling Medical Records

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog: Biosimilars

MAY 8, 2023

FDA recommends manufacturers submit each modification, associated labeling changes and specific performance evaluation in the Modification Protocol (MP). Update procedures : The MP should describe how the manufacturer will update the software and any associated labeling that will be required for the modifications.

Documentation

Documentation Labelling

Court Decision Dilutes Hopes of Homeopathic Industry for New Regulatory Pathways

FDA Law Blog: Biosimilars

JULY 31, 2025

In 2019, the agency withdrew that CPG and issued draft guidance describing its new risk-based enforcement policy to replace the CPG. In 2015, FDA indicated that it increasingly was concerned about the safety of homeopathic drugs, and it claimed that the existence of the CPG limited its options to take enforcement action.

Documentation

Documentation Labelling

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31

Documentation

Documentation Packaging Communication Labelling

Nine for 2021: Addressing the pandemic legacy

pharmaphorum

JANUARY 14, 2021

The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts.

EMA starts review of Enhertu for HER2+ gastric cancer

pharmaphorum

NOVEMBER 3, 2021

Around one in five gastric cancers are HER2-positive, opening up a new market for AZ and Daiichi Sankyo, which have been collaborating on Enhertu since signing a multi-billion partnership for the drug in 2019. The post EMA starts review of Enhertu for HER2+ gastric cancer appeared first on.

Chemotherapy

Chemotherapy Labelling Biosimilars

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling

Labelling Vaccines Communication

ICH Q6B for Analytics

PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.

Dosage

Dosage Drug Development Documentation Biosimilars

Pharma in Brief: The 2022 Year in Review

Pharma in Brief

JANUARY 25, 2023

Changes to how the PMPRB reviews prices In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use.

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

PharmaShots

APRIL 13, 2023

Novartis intended to separate its eye care division, Alcon, into an independent company which is expected to be completed in 2019. summing the revenue to $29.63B In the year 2019, Roche held the second position among the top 20 biopharma companies with the sales of $63.5B stake in GSK Consumer Healthcare to GSK.

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law Blog: Biosimilars

JUNE 2, 2023

“All In” Manufacturer Definition CMS believes that the National Rebate Agreement (NRA) requires a “manufacturer” to report to Medicaid all of its covered outpatient drugs, under all of its labeler codes. This includes newly acquired labeler codes and newly formed subsidiaries. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

Labelling

Labelling Vaccines Drug Pricing Immunization

A history of Johnson & Johnson

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. billion) hit the company in 2019. But like many of its big pharma peers, it faces increased pressure on some of its biggest brands, as expiring patents pave the way for generic competition while biosimilars undercut sales of biologics.

Vaccines

Vaccines Labelling Biosimilars Communication

PharmaShots' Key Highlights of First Quarter 2023

PharmaShots

APRIL 3, 2023

The system offers alternative options for those patients receiving other medications The system was originally approved in 2019 for treating chronic pain. The authorization incl. multiple indications such as RA & Crohn's disease Hyrimoz was originally approved by the EC in 2018 with a concentration of 50mg/mL.

OPDP’s One-Two Combo on Quantitative Efficacy Claims in DTC Ads

FDA Law Blog: Biosimilars

DECEMBER 18, 2023

The letters come on the heels of FDA finalizing its Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. Both letters addressed quantitative efficacy presentations—attacking the numbers as well as the underlying methodology for obtaining those numbers.

Labelling

Labelling Pharmaceutical Companies Pharmaceutical Companies

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law Blog: Biosimilars

MAY 13, 2025

In examining imported drugs sent through the mail, FDA has identified unapproved drugs, counterfeit drugs, improperly labeled drugs, drugs that failed to meet special storage conditions, and drugs that require supervision of a practitioner licensed by law to administer them. See Proposed Rule, Importation of Prescription Drugs , 84 Fed.

Online Pharmacies

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing

Dilemma for Biden as Woodcock’s audition for FDA chief stumbles

pharmaphorum

FEBRUARY 5, 2021

The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. Abernethy only joined the agency in 2019 and although she clearly has some fresh ideas about how the FDA could be run, she lacks Woodcock’s experience in the organisation”.

Vaccines

Vaccines Labelling Biosimilars

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Trending Sources

Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

Pharmacists Have a Crucial Role Helping Patients With ATTR-CM Navigate Treatment With Tafamidis

Gabapentin Use Linked to Increased Dementia Risk in Chronic Back Pain Patients

Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

To Combat Medication Errors, Proper Pharmacy Inventory Counts Are Essential

J&J eyes prostate cancer label expansion for Akeega

From data to impact: How real-world evidence will transform healthcare

Smarter learning and better outcomes: How AI can provide an advantage in medical education

Why security-first design is the fix to stalling AI pilot tools

To 513(g) or not to 513(g)? That is the question

J&J bids to extend prostate cancer uses for Akeega

Moderna shines spotlight on new flu vaccine data

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

May 2024 Newsletter

Boost for AZ as Ultomiris gets CHMP nod for expanded label

T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Moving towards oral delivery of biologics

Dermavant claims its first approval as FDA clears psoriasis drug

PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Court Decision Dilutes Hopes of Homeopathic Industry for New Regulatory Pathways

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

Nine for 2021: Addressing the pandemic legacy

EMA starts review of Enhertu for HER2+ gastric cancer

FDA-Approved Labeling: Is Enough Enough?

ICH Q6B for Analytics

Pharma in Brief: The 2022 Year in Review

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

A history of Johnson & Johnson

PharmaShots' Key Highlights of First Quarter 2023

OPDP’s One-Two Combo on Quantitative Efficacy Claims in DTC Ads

Contents

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

Dilemma for Biden as Woodcock’s audition for FDA chief stumbles

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