Drug Channels

SEPTEMBER 4, 2024

The Humira biosimilar market just took another step forward—but remains far from its ideal state. Last week, Cigna’s Express Scripts announced that it that will follow CVS Health’s CVS Caremark business and remove Humira from its largest commercial formulary in favor of multiple biosimilars.

Biosimilars 52

Biosimilars Labelling 52

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.

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

JANUARY 5, 2025

Turning first to the four areas in which changes were made, the focus of two of those areas were the requirements for the required labeling statements for a product approved with an ACNU. The final rule becomes effective on January 27, 2025. The third was the postmarketing requirement for reporting an ACNU failure.

Labelling 59

Labelling 59

Big Molecule Watch

DECEMBER 28, 2023

Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Reddy’s Laboratories Ltd. (“Dr.

Biosimilars 69

Biosimilars Labelling 69

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

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. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. That litigation is ongoing.

Biosimilars 45

Biosimilars Drug Pricing Labelling Communication 45

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.

Documentation 69

Documentation Labelling 69

Big Molecule Watch

JUNE 29, 2023

As we previously reported , Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. The Court also noted that Biogen’s own expert cited sources showing that, in the 12-18 months after biosimilar launch, the price of the biosimilar product remained stable.

Biosimilars 52

Biosimilars Labelling 52

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.”

Labelling 52

Labelling 52

Big Molecule Watch

AUGUST 25, 2023

With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. Drugs are considered to be “qualifying single-source drugs” if they have been without generic or biosimilar competition for a certain number of years.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

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.

Documentation 52

Documentation 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.

Documentation 52

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.

Labelling 64

Labelling Communication 64

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.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

Biosimilars 56

Biosimilars Labelling Diabetes 56

Pharmacy Times

JUNE 9, 2025

The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. 43, 2025 (suppl 17; abstr LBA1000). Updated March 13, 2025.

Pharmacy Technician 29

Pharmacy Technician Compounding Pharmacies Pharmacy Management Immunization 29

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.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

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). So why is ICH Q6B so important, and what does it outline?

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

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. Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. Focus on customer engagement impact.

Biosimilars 71

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

Pharmacy Times

JUNE 16, 2025

1 The findings were presented at the Revolutionizing Atopic Dermatitis (RAD) 2025 conference held in Nashville, Tennessee. RAD 2025: Long-term data on Nemluvio® (nemolizumab) demonstrate its favorable safety profile and sustained and increased improvements in itch and skin lesions in patients with atopic dermatitis up to two years.

Pharmacy Technician 26

Pharmacy Technician Biosimilars Compounding Pharmacies Pharmacy Management 26

Pharmacy Times

JUNE 11, 2025

Completion Date (Estimated): December 31, 2025 TRUST-II Trial Name: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC (TRUST-II) ClinicalTrials.gov ID: NCT04919811 Sponsor: Nuvation Bio Inc. June 11, 2025. Accessed June 11, 2025. June 11, 2025. Accessed June 11, 2025. News release. Businesswire.

Pharmacy Technician 26

Pharmacy Technician Biosimilars Compounding Pharmacies Pharmacy Management 26

Pharmacy Times

JUNE 11, 2025

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. Zanubrutinib tablets are set to replace capsules beginning in October 2025, according to the news release. Released June 11, 2025. News Release.

Pharmacy Technician 26

Pharmacy Technician Compounding Pharmacies Biosimilars Pharmacy Management 26

Pharmacy Times

JUNE 9, 2025

At the 2025 American Society of Health-System Pharmacists (ASHP) Pharmacy Futures meeting, 4 pharmacy leaders from major health systems gathered for a candid panel discussion about the rapidly evolving role of pharmacists in managing advanced therapeutics, including cell and gene therapies. Accessed June 9, 2025.

Pharmacy Technician 22

Pharmacy Technician Compounding Pharmacies Hospitals Pharmacy Management 22

FDA Law Blog: Biosimilars

MARCH 6, 2025

adding labels or tags to raw data), as is done in semi-supervised or supervised machine learning, the annotation process and credentials of the annotators should be documented. The DCP should address if there are missing data elements (e.g., If the data collected will be annotated (e.g.,

Documentation 105

Documentation Inpatient Labelling Hospitals 105

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.

Labelling 64

Labelling Communication Documentation 64

Pharmacy Times

JUNE 12, 2025

Accessed June 12, 2025. Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). February 1, 2025. June 12, 2025. Accessed June 12, 2025. June 12, 2025. Accessed June 12, 2025. Front Oncol.

Pharmacy Technician 26

Pharmacy Technician Biosimilars Compounding Pharmacies Pharmacy Management 26

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.

Drug Development 59

Drug Development Communication Documentation Labelling 59

Pharmaceutical Commerce

JUNE 17, 2025

This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Jeff Webber Key Takeaways Real-world data enhances medication safety and supply chain efficiency.

52

52

Pharmacy Times

JUNE 9, 2025

These findings, which were presented at the 2025 American Society of Clinical Oncology in Chicago, Illinois, suggest that omitting carboplatin from treatment regimens could be an efficacious de-escalated neoadjuvant strategy in this patient population. If caught early, the cancer can often be treated and cured, according to Cleveland Clinic.

Pharmacy Technician 26

Pharmacy Technician Compounding Pharmacies Hospitals Pharmacy Management 26

Pharmacy Times

JUNE 15, 2025

In the randomized, open-label, multicenter phase 3 NATALEE clinical trial (NCT05306340), ribociclib (Kisqali; Novartis) plus endocrine therapy, a nonsteroidal aromatase inhibitor (NSAI), significantly improved invasive disease-free survival among individuals with HR-positive (HR+) and HER2-negative (HER2-) early breast cancer. Mayo Clinic.

Pharmacy Technician 29

Pharmacy Technician Mayo Clinic Compounding Pharmacies Pharmacy Management 29

Pharmacy Times

JUNE 12, 2025

Molecular model of pembrolizumab | Image Credit: © Dr_Microbe - stock.adobe.com The FDA’s decision was based on data from the randomized, multicenter, open-label KEYNOTE-689 trial (NCT02358031). Accessed June 12, 2025. June 12, 2025. Accessed June 12, 2025. Updated September 20, 2024.

Pharmacy Technician 32

Pharmacy Technician Compounding Pharmacies Pharmacy Management Immunization 32

Pharmacy Times

JUNE 9, 2025

These conclusions were presented as part of an abstract from the open-label, phase 3 CheckMate 816 trial (NCT02998528) at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, and subsequently published in the Journal of Clinical Oncology. Last Updated January 24, 2025. Accessed June 9, 2025.

Chemotherapy 26

Chemotherapy Pharmacy Technician Immunization Immunity 26

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). Biosimilars, stated “This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025.”

Biosimilars 64

Biosimilars Labelling 64

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists.

Labelling 52

Labelling Documentation Packaging 52

FDA Law Blog: Biosimilars

MAY 29, 2025

Javitt On May 8, 2025, FDA announced the successful completion of a generative artificial intelligence (AI) scientific review pilot program aimed at accelerating the review process and an aggressive timeline to rollout the use of AI tools across the Agency. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

Labelling 102

Labelling Documentation 102

FDA Law Blog: Biosimilars

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

Documentation 105

Documentation Labelling 105

Big Molecule Watch

MAY 2, 2025

Samsung) from launching a private label biosimilar of Janssens STELARA (ustekinumab) in a breach of contract case. As we previously reported , on November 30, 2023, Janssen and Samsung settled the BPCIA litigation over Samsungs ustekinumab biosimilar. The courts opinion is currently under seal.

Biosimilars 52

Biosimilars Labelling 52