FDA Law Blog: Biosimilars

JULY 27, 2025

In those orders, Chief Judge Mulrooney announced that he was retiring from the bench effective August 1, 2025, and that, in the absence of any other DEA ALJs, all proceedings and hearing dates are postponed indefinitely. Where does this leave DEA and all of the DEA registrants with pending or contemplated administrative actions?

Regulations

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands? Also, to be sure, quality still matters in the drug and device industries. Trusting suppliers is still fundamental to any drug or device manufacturer.

Compliance

FDA Law Blog: Biosimilars

APRIL 7, 2025

Indeed, most Center for Veterinary Medicine (CVM) Warning Letters arise because products advertised are actually new animal drugs. But this year, CVM has issued two notable warning letters and one Untitled Letter concerning the promotion of animal drugs that caught our attention because of the level of detail and specificity included.

Vaccine

Alta Sciences

JUNE 26, 2025

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Pharmacokinetics

Drug Channels

JULY 8, 2025

The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared. As always, with great pricing power comes great responsibility. All rights reserved.

Biosimilars

The Pharma Data

JUNE 6, 2025

CSOs allow pharmaceutical firms to scale sales operations rapidly , particularly during drug launches , geographic expansions , product lifecycle extensions , and co-promotion agreements. Biosimilars and Generics : Where cost competition necessitates strategic brand differentiation and efficient coverage. In the U.S.,

Pharmaceutical Companies

Alta Sciences

JUNE 26, 2025

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Pharmacokinetics

FDA Law Blog: Biosimilars

APRIL 7, 2025

Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institutes 23rd Advanced Summit on Life Sciences Patents , which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY.

Science

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Drugs/Biologics/Devices / Tobacco (CDER, CBER, CDRH, CTP) These centers are largely supported by user-fee programs that support their review staff (MDUFA, PDUFA, BsUFA, GDUFA). By Richard A.

Government

FDA Law Blog: Biosimilars

JUNE 1, 2025

Senator Dick Durbin (D-IL) expressed concerns over the agencys ability to regulate direct-to-consumer (DTC) prescription drug advertisements following recent workforce reductions. Department of Health and Human Services Secretary, Robert F. Kennedy Jr., stating that he would advise President Trump to ban pharmaceutical advertising on TV.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

APRIL 8, 2025

As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA. Leading FDAs implementationof the Drug Competition Action Plan (DCAP). And DPD was a significant piece of that puzzle. facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

FDA

FDA Law Blog: Biosimilars

MAY 19, 2025

Attorneys Office, Northern District of Illinois, April 21, 2025. Prescriptions of drugs or drug combinations that are frequently sought by individuals known to abuse or misuse prescription drugs, including the combination of an opioid, a benzodiazepine and a muscle relaxant, known as the trinity. 81, 86, 251.

Doctors

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And it is exactly that!

FDA

FDA Law Blog: Biosimilars

JANUARY 5, 2025

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. By Deborah L. 105288 (Dec.

FDA

Drug Channels

APRIL 1, 2025

Click here to see the original post from January 2025. For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. You can find our updated counting below.

Biosimilars

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. By Steven J. Gonzalez & Allyson B. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. In Neumanns Pharmacy, LLC , 90 Fed.

Testimonials

FDA Law Blog: Biosimilars

JULY 13, 2025

Snow — On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025. By Charles D.

FDA

Drug Channels

JUNE 17, 2025

Click here to see the original post from March 2025. Below, we break down the latest market share data from Drug Channels Institute (DCI), explore the developments driving these changes, and examine what they signal for the future of the PBM landscape. Three’s still company in the world of pharmacy benefit managers.

Pharmacy

FDA Law Blog: Biosimilars

MARCH 31, 2025

Gonzalez On March 31, 2025, U.S. That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests. By Steven J. District Judge Sean D.

Laboratories

Drug Channels

MARCH 26, 2025

Spring has officially arrived in sunny downtown Philadelphiathe proud home base of Drug Channels. As you can see on the right, we celebrated in Miami at the Drug Channels Leadership Forum. on April 4, 2025, from 12:00 p.m. Read more 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

Biosimilars

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.

FDA

Alta Sciences

JULY 3, 2025

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Marketing

FDA Law Blog: Biosimilars

JUNE 3, 2025

Attorneys Office, Northern District of Illinois, April 21, 2025, quoted here. Press Release, Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S.

Pharmacy

FDA Law Blog: Biosimilars

MARCH 6, 2025

This statement followed a February 20, 2025 letter from Acting Solicitor General Sarah Harris to President Pro Tempore of the Senate Charles Grassley stating the same and noting that the Department will no longer defend the layers of removal restrictions for ALJs in court. Bondi , No. 3:23-cv-2883-E, ECF No.

Government

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

Drugs

Drugs.com

FEBRUARY 19, 2025

19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus. WEDNESDAY, Feb. Merilog is a rapid-acting human.

Biosimilars

FDA Law Blog: Biosimilars

MARCH 12, 2025

The American Conference Institutes 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S.

FDA

Drugs.com

FEBRUARY 19, 2025

19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.Merilog is a rapid-acting human. WEDNESDAY, Feb.

Biosimilars

Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

Biosimilars

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.

FDA

BioPharma Drive: Drug Pricing

JULY 22, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 headquarters in Bridgewater, New Jersey.

Vaccine

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

I will be presenting Recent Hospital Employee Diversion: Mistakes Made, Lessons Learned, focusing on this timely topic, at the World Conference Forums 2025 Opioid & Fentanyl Abuse Management Congress in San Diego on February 20th. Employee diversion can also result in unwanted local and national publicity.

Hospitals

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. All rights reserved.

Biosimilars

FDA Law Blog: Biosimilars

JULY 8, 2025

On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed products. What does this mean?

FDA

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. The revisions due in 2025 include testing for NDSRIs.

Small Molecule

Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

Biosimilars