pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

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European Pharmaceutical Review

DECEMBER 20, 2023

1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. If EP revisions are adopted, originators may see increased commercial value of non-orphan drugs dependent on RDP, given the one-year delay of generic / biosimilar entry compared to current regulations.

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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.

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Documentation Labelling 69

European Pharmaceutical Review

FEBRUARY 22, 2023

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. Under the agreement, Celltrion will exclusively supply to Rani the ustekinumab biosimilar drug substance (CT-P43) required for its RT-111 programme.

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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).

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FDA Law Blog: Biosimilars

MAY 8, 2023

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. Updates performed automatically will face a “higher bar” for demonstrating safety and effectiveness.

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Documentation Labelling 98

FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence. on March 10, 2020. Advantage, OPDP.

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Labelling Adverse Reactions Dosage 59

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. Premier Consulting [Internet]. 2018 [cited 2024May].

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Drug Development Documentation Labelling Biosimilars 103

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Breztri was approved just over 3 years ago in July 2020 for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). In a post-CFL world , these claims walk the line in that they could be “consistent” with the FDA-required labeling in accordance with FDA’s stated 3-factor analysis.

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FDA Law Blog: Biosimilars

JULY 2, 2025

Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its regulatory oversight for over-the-counter (OTC) products. By Charles D. Snow — Since the U.S.

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FDA Law Blog: Biosimilars

JUNE 22, 2023

Regarding COVID-19, Tim Stenzel, Director of CDRH’s Office of In Vitro Diagnostics, has stated that “in-home testing and home collections is a top priority” ( June 2020 FDA Virtual Town Hall ); “obviously home over-the-counter tests including rapid antigen tests are a high priority” ( February 2021 FDA Virtual Town Hall ). lay users).

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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

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Documentation Packaging Communication Labelling 75

Putting Patients First Blog

JUNE 26, 2025

CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. April 14, 2023.

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Drug Pricing Communication Drug Development Documentation 52

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Increased transparency will ensure that formulary practices align with broader goals of affordability and patient access.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

pharmaphorum

JANUARY 14, 2021

The customer engagement story of 2020 could be summarised in three themes: trend break, agility and remote interaction. For April 2020 almost all face-to-face contact with healthcare professionals (HCPs) ceased. Up to November, the US and Japan actually saw increases in interactive time in 2020.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

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. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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Labelling Vaccines Communication 40

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. 1396r-8(b)(3)(C)(i).

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Labelling Vaccines Drug Pricing Immunity 59

PharmaShots

APRIL 13, 2023

The company faced a tough time in 2019 as the first biosimilars for its best-selling drugs (Rituxan, Avastin, and Herceptin) emerged. from 2018 to 2019 Roche’s blockbuster drugs, Herceptin, Avastin, and Rituxan played significantly well against its biosimilar products. Moreover, its medical device sales faced a decline of 1.7%

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FDA Law Blog: Biosimilars

JULY 9, 2024

Would any such failure to meet DAP goals be reflected in labeling? The current requirements are limited to having a DAP – it remains to be seen how FDA will evaluate whether or what actions it might take if goals are not met or if FDA concludes adequate good faith efforts were not employed to implement the DAP.

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Drug Development Communication Documentation Labelling 59

Safe Biologics

APRIL 10, 2023

Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing. Sandoz intends to launch the biosimilar in the United States on July 1, 2023. Read about the approval here.

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Biosimilars Drug Pricing Diabetes Labelling 130

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. And at the tail end of 2020, a $6.5 As with most of the pharma industry, J&J’s financials were hit by COVID uncertainty in 2020, the impacts of which may be felt for years to come. COVID and beyond.

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Vaccines Labelling Biosimilars Communication 126

pharmaphorum

NOVEMBER 10, 2022

Horizon Europe and cancer care post-2020. With ten times more budget than before, Montserrat reminded attendees that cancer was one of the five main missions of the Horizon Europe programme, which picks up from where Horizon 2020 left off. What she also highlighted was the European Commission’s proposal for cancer screening.

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Vaccines Labelling Biosimilars Pharmaceutical Companies 97

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JANUARY 2, 2025

In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.

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Labelling Documentation 52

FDA Law Blog: Biosimilars

MAY 13, 2025

Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have. Given that the provision in the May 12 EO may be a rehash of what occurred in 2020, we thought it would be helpful to provide a bit of history and background on personal importations. Kevin McCarthy (Sept.

Online Pharmacies 59

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing 59

Pharmacy Times

JUNE 16, 2025

The first one was introduced on September 13, 2020, near the end of Trump’s first term, but was shut down by a federal judge due to the administration’s failure to comply with the proper implementation processes. September 13, 2020. Trump to pitch sweeping Medicare drug price plan. May 7, 2025. Accessed May 13, 2025.

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