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

SEPTEMBER 21, 2022

After its US approval, analysts at Piper Sandler predicted sales would reach $500 million in 2023, and top $1 billion by 2025, while Jefferies is reckoning on peak sales of $1.5 billion or more.

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Labelling 111

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

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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Chemotherapy Labelling 98

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 69

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

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

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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Diabetes Labelling Immunity Immunization 98

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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Labelling Immunity Immunization 52

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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Biosimilars Labelling Drug Pricing 45

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. The study included 92 adult patients with confirmed CDI. Overall, MBK-01 has potential to be an effective, easy-to-administer, low-risk treatment for CDI. References van Prehn J, Reigadas E, Vogelzang EH, et al.

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Documentation Labelling Hospitals 111

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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Chemotherapy Labelling 52

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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Dosage Labelling 52

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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Documentation Labelling 52

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

pharmaphorum

NOVEMBER 30, 2021

Mizuho’s Salim Syed has previously said that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion. Sales of PDE4 inhibitor Otezla grew 13% in the third quarter to $609 million, but analysts have suggested it will come under pressure from deucravacitinib if approved.

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Labelling 52

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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Biosimilars Labelling 69

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. 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.

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Documentation Labelling 69

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

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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Labelling Compounding 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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Documentation Labelling 52

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

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

pharmaphorum

DECEMBER 29, 2021

Dupixent’s label currently calls for dosing every two weeks for all patients. The company has put tralokinumab at the heart of plans to significantly expand its product sales, R&D pipeline and global presence by 2025. after a lead-in period of dosing every other week. billion in 2020. with #AtopicDermatitis.

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Labelling 111

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

PharmaShots

MAY 3, 2023

The results showed that CT-P42 met the predefined equivalence criteria of ±3 letters, and 2EPs of efficacy, safety, and immunogenicity also showed similar trends to Eyela Eylea is expected to reach substance patent expiration in the US in June 2023 and in the EU in May 2025. Infections were observed in 33.9%

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Biosimilars Labelling Diabetes 56

pharmaphorum

JANUARY 14, 2021

CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade. 2020 was a year in which, by rising to the challenge of the pandemic, the pharmaceutical industry demonstrated it can accomplish that which would previously have been labelled impossible. About the author.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

FDA Law Blog: Biosimilars

JULY 9, 2024

Would any such failure to meet DAP goals be reflected in labeling? This means, under Congress’s direction in FDORA, the FDA should be trying to finalize the Draft Guidance around June 2025. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

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Drug Development Communication Documentation Labelling 59

Big Molecule Watch

SEPTEMBER 17, 2024

WHO’s announcement added that the “vaccine may be used ‘off-label’ in infants, children and adolescents, and in pregnant and immunocompromised people.” It further added that it “could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024.”

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Vaccines Labelling 49

ID Stewardship

DECEMBER 11, 2024

I wonder if this will cause us to be more fragmented as a group in 2025 and if Bluesky will really have sticking power. With Twitter changing to X in mid-2023 and subsequently in the end of 2024 many folks from the IDtwitter community moving over to Bluesky, the game is certainly ever-changing. Mastodon sure did not.

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HIV Treatment and Prevention Agents Labelling Hospitals Communication 144

Big Molecule Watch

OCTOBER 31, 2024

This new presentation allows for SELARSDI to expand its label to align with the indications of the reference product STELARA® (ustekinumab). launch of SELARSDI approaches in early 2025.” Thomas Rainey, Senior Vice President, U.S.

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Biosimilars Labelling 64