FDA Law Blog: Biosimilars

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J. Gonzalez & Allyson B. The Warning Letter seems to echo this point.

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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.

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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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Pharmacy Times

JULY 2, 2025

The CRL was received after OLC’s initial Prescription Drug User Fee Act date of June 28, 2025, and cited for deficiencies that are unrelated to OLC itself. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis. June 30, 2025.

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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.

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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.

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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.

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pharmaphorum

JULY 2, 2025

Her career kicked off at 18, when she landed a role at Check Point after successfully cracking a series of online cybersecurity challenges the company had labelled as nearly unsolvable. Image Siwar El Assad 2 July, 2025 AI in pharma Bookmark this Market Access Balancing efficiency with risks: How biopharma companies can.

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

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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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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.

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FDA Law Blog: Biosimilars

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L. Butler & Deborah L.

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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.

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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.

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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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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. It’s 2025. So, good talking to you. Matt Paterini (01:21): No, we appreciate the time. And remember, COVID was in there too, right?

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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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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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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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Pharmacy Times

JUNE 23, 2025

1 Image credit: Cynthia | stock.adobe.com The discussion featured Vivian Fonseca, MD, of the Tulane University School of Medicine, who presented an overview of tirzepatide based on the FDA-approved label and clinical guidelines. Presented: 85th Scientific Sessions of the American Diabetes Association; June 23, 2025; Chicago, Illinois.

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Pharmacy Times

JUNE 23, 2025

Completion Date (Estimated): May 2025 Lorundrostat is an oral, highly selective aldosterone synthase inhibitor (ASI) under development for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and obstructive sleep apnea. Updated February 21, 2025. Accessed June 17, 2025.

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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.

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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. Accessed May 15, 2025. Accessed May 15, 2025. Accessed May 15, 2025. Carlstrom, PharmD, BCOP , Joseph A.

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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.

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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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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?

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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.

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Pharmacy Times

JUNE 20, 2025

In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Accessed May 12, 2025. Accessed May 12, 2025. Accessed May 12, 2025. Accessed May 12, 2025.

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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.

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Pharmacy Times

JUNE 30, 2025

Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. Still, providing accurate product labeling for these products—which properly conveys the risks of CRS and neurological toxicities—remains essential to ensuring patient safety. Released June 27, 2025. News Release.

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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.

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Pharmacy Times

JUNE 23, 2025

Soefje, PharmD, MBA, BCOP, during the Hematology/Oncology Pharmacy Association (HOPA) 2025 Annual Conference in Portland, Oregon. Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. REFERENCE Soefje SA.

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Pharmacy Times

JUNE 23, 2025

Updated June 3, 2025. Accessed June 23, 2025. Updated March 30, 2025. Accessed June 23, 2025. Accessed June 23, 2025. June 19, 2025. Accessed June 23, 2025. June 23, 2025. Accessed June 23, 2025. Navigating EGFR mutations and ALK fusions in early-stage non-small cell lung cancer.

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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.

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Pharmacy Times

JUNE 30, 2025

The data from an ongoing phase 1 LIMBER trial (NCT04279847) were presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago. Updated June 12, 2025. Accessed June 30, 2025. Continued study is needed to further elucidate INCB057643’s place in the MF treatment paradigm. REFERENCES 1.

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Pharmacy Times

JULY 1, 2025

1 To evaluate how temperature information is stored in the mouse brain, researchers designed a thermoregulatory Pavlovian conditioning experiment using engram labeling technology, which is a physical change in the brain that accounts for a specific memory. Published online April 23, 2025. Accessed May 13, 2025. April 23, 2025.

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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.,

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