FDA Law Blog: Biosimilars

MARCH 23, 2025

Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. By Deborah L.

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Labelling 59

Express Pharma

JANUARY 17, 2025

Caplyta is currently under FDA review for major depressive disorder (MDD), with a decision anticipated in the first half of 2025. Opdenakker continues, The addition of Caplyta could be particularly significant, given its versatility as a proven treatment for schizophrenia and bipolar disorder, as well as a potential label expansion into MDD.

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Labelling 105

Pharmafile

JANUARY 23, 2025

Award winners by category DELIVERY AND DEVICE INNOVATION SHL Medical for Elexy reusable electromechanical autoinjector ECO-DESIGN WINNER Huhtamaki for Omnilock Ultra PAPER PACKAGING INNOVATION WINNER Mitsubishi Gas Chemical Company for new OXYCAPT Multilayer Plastic Vial PATIENT-CENTRIC DESIGN WINNER UCB Pharma for Bimzelx 160mg 2ml autoinjectors product (..)

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LifeProNow

JANUARY 18, 2025

January 15, 2025 : “Johnson & Johnsonannounced it has initiated the submission of an original New Drug Application with the U.S.

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Pharmaceutical Commerce

FEBRUARY 21, 2025

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on other concepts that are powering the companys 2025 Supply Chain Trends Report, and how they could possibly change in 2026.

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Labelling 52

Pharmaceutical Technology

NOVEMBER 15, 2024

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

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Labelling 52

Drug Channels

SEPTEMBER 4, 2024

Below, we review the 18 products competing with Humira—including four private-label products marketed by in-house subsidiaries owned by CVS Health and Cigna. Express Scripts’ 2025 strategy will also drive biosimilar adoption, although its pricing strategy is more problematic.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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Labelling Drug Pricing Compounding Payment Processing 105

European Pharmaceutical Review

AUGUST 17, 2022

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

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Pharmaceutical Manufacturing Dosage Packaging Labelling 96

European Pharmaceutical Review

OCTOBER 31, 2023

Galapagos also agreed to pay up to €40 million by June 2025 to Alfasigma for development activities.

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Labelling 105

pharmaphorum

OCTOBER 26, 2022

The drug was highlighted at Boehringer’s R&D update earlier this year as one of the most promising candidates among 15 new medicines it plans to bring to market by 2025, fuelled by a €25 billion R&D spend. billion a 25% gain in the prior year and fuelled in part by extensions to its label to include other progressive ILDs.

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Labelling 98

pharmaphorum

JUNE 6, 2022

It will, however, add to BMS’ earnings potential from 2025 – when the company will start to bear the brunt of patent expiries on key drugs, including $12.8 billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

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The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 270 expiring in March 2025.)

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Health and Personal Care Stores Immunity Immunization Labelling 73

FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. report certain device malfunctions, and.

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Labelling Communication Documentation 64

PhRMA

FEBRUARY 13, 2025

Currently, AOMs are excluded from Medicare Part D coverage and optional in state Medicaid programs, when used specifically for the treatment of obesity, because they’re labeled as “agents used for weight loss.”

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Labelling 52

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis. Otezla was acquired by Amgen for $13.4

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European Pharmaceutical Review

MARCH 14, 2024

Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN.

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Diabetes Labelling Immunity Immunization 98

European Pharmaceutical Review

MARCH 14, 2024

Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN.

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pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

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Big Molecule Watch

JANUARY 25, 2024

According to a reported statement from Amgen, its settlement agreement with Janssen allows Amgen to sell WEZLANA “no later than January 1, 2025.” (CMS’s position on this has been challenged in pending litigation.)

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RX Note

NOVEMBER 12, 2024

Following this announcement, the legacy apps such as Micromedex Drug Reference , Micromedex Drug Interactions and Micromedex IV Compatibility , will lose support in February 2025. In my experience, there are increasingly more off-label uses and dosages included in this resource. USD a year for Micromedex Drug Reference ).

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FDA Law Blog: Biosimilars

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023.

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Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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Packaging Labelling 52

Quality Matters

SEPTEMBER 9, 2024

By engaging in roundtable discussions, drafting stimuli articles, and developing work plans with HQS Expert Committees, USP is setting high-quality standards, covering aspects such as labeling, version control, classification, health equity, and accessibility.

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Labelling Diabetes 52

Big Molecule Watch

JUNE 29, 2023

As for Biogen’s patents directed to methods of assessing risk, the Court found that Sandoz’s label, taken in its entirety, did not encourage, recommend, or promote infringement. In the Court’s order, it also noted that it will “try its best to schedule a trial before April 2025.”

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Biosimilars Labelling 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Structure of the eSTAR for De Novos The draft guidance provides a table that offers a high-level overview of the structure of the eSTAR for De Novos, including elements such as the cover letter, device description, proposed indications for use, classification, benefits, risks, mitigation measures, labeling, and supporting data.

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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. pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. Here are some of the top regulatory developments from 2024.

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Biosimilars Drug Pricing Labelling Communication 45

Quality Matters

MARCH 1, 2024

In the meantime, USP encourages interested parties to reach out for more information as USP approaches its new 2025-2030 cycle. These future articles will feature in the USP-PF and will solicit public comment to promote stakeholder engagement.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Stage 1 is scheduled to take effect on May 6, 2025. FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion.

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Labelling Communication 64

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

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Immunity Immunization Vaccines Health and Personal Care Stores 40

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. Accessed January 2, 2025. ” Accessed January 9, 2025. 14 National Health Council. 39 Patient Access Network Foundation. 42 Maria T.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

Big Molecule Watch

AUGUST 25, 2023

Beginning in 2025, CMS will publish its selected drugs on February 1.) Thereafter, CMS will select 20 additional products each year. Note that the specific deadlines for each step of the Program are adjusted for the first two years of the Program.

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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

European Pharmaceutical Review

NOVEMBER 1, 2024

billion in 2025 to approximately $174.45 Otherwise, advanced technological features such as “Advanced Recycling PET or Carbon Capture PET” as well as “labelling and sensory tracking systems” offer opportunities too, Towards Packaging asserted. billion by 2033, according to a study published by Towards Packaging.

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Packaging Dosage Labelling Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 7, 2023

Mounjaro’s approval in 2022 for T2D has already led to many prescribers providing the therapy off-label to their patients to help them lose weight. Lilly is currently in the midst of initiating a head-to-head Phase IIIb trial for Mounjaro in comparison to Wegovy, which the company expects to conclude in early 2025.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 98

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. The following new measures are set to be introduced on 1 January 2025. After this date: Under the framework, medicines can have the same packaging and labelling across the UK.

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Packaging Labelling 105

Big Molecule Watch

DECEMBER 28, 2023

Coya later reported its 48-week clinical data for a proof-of-concept open-label study in 4 patients with amyotrophic lateral sclerosis (ALS) demonstrating that treatment with COYA 302 appeared to ameliorate disease progression. Dr. Reddy’s will have exclusive rights to the same in areas outside of these territories.

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Pharmaceutical Business Review

JUNE 10, 2024

A decision on the approval under the Prescription Drug User Fee Act (PDUFA) is anticipated on 25 January 2025. The sBLA is based on the modelling of observed data from a Phase II trial, Study 201, and its open-label extension (OLE) part as well as the Clarity AD study (Study 301) and its OLE study.

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Labelling 59