FDA Law Blog: Biosimilars

APRIL 13, 2025

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). Both cases involve oncology drugs granted accelerated approval. What Happened?

Drugs 52

Drugs FDA Trials Treatment 52

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 52

Biosimilars Pharmacy Drugs 52

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 144

FDA Drugs Production Drug Development 144

Drug Target Review

JUNE 16, 2025

G protein-coupled receptors (GPCRs) are a highly validated drug target family – accounting for 30-35 percent of all approved drugs. Despite this, the therapeutic potential of targeting most GPCRs remains untapped, as only 10 percent of GPCRs have been drugged.

Disease 59

Disease Therapies Small Molecule Immune Response 59

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 52

Biosimilars Production Marketing Drugs 52

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 59

FDA Production Compliance Drugs 59

Alta Sciences

JUNE 26, 2025

All Rights Reserved. Cookie Policy | Privacy Policy Have a question? × Id be happy to help. No, thanks. Captcha is required.

Pharmacokinetics 40

Pharmacokinetics Testimonials Biosimilars Drug Development 40

Alta Sciences

JUNE 26, 2025

All Rights Reserved. Cookie Policy | Privacy Policy Have a question? × Id be happy to help. No, thanks. Captcha is required.

Pharmacokinetics 40

Pharmacokinetics Testimonials Biosimilars Drug Development 40

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 40

Pharmaceutical Companies Compliance Pharmaceuticals International 40

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 111

Laboratories FDA Regulations Drugs 111

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 66

Compliance Regulations FDA Government 66

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 40

Biosimilars Science FDA Production 40

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 105

Small Molecule FDA Production Drugs 105

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 52

Pharmacy Marketing Drugs Research 52

Drug Channels

JUNE 25, 2024

Join my nearly 57,000 LinkedIn followers for daily links to neat stuff along with commentary from the Drug Channels community. Note that we will soon migrate our social media activity to the Drug Channels Institute LinkedIn page. Attendance will be limited, so click here to request an invite for our March 2025 event.

Biosimilars 40

Biosimilars Drugs Pharmacy 40

FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (

Pharmaceutical Companies 59

Pharmaceutical Companies FDA Production Regulations 59

Alta Sciences

JULY 3, 2025

All Rights Reserved. Cookie Policy | Privacy Policy Have a question? × Id be happy to help. No, thanks. Captcha is required.

Marketing 40

Marketing Pharmacokinetics Testimonials Biosimilars 40

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 64

Doctors Pharmacy Drugs Government 64

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 59

FDA Clinical Trials Regulations Production 59

FDA Law Blog: Biosimilars

JUNE 25, 2025

To be clear, the minor changes are permitted only for OTC monograph drug products that are included in deemed final orders, and not for OTC monograph products that may remain on the market pending FDA monograph orders allowing or prohibiting such products.)

FDA 59

FDA Packaging Drugs Production 59

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 59

FDA Regulations Drugs Production 59

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 59

Science Government FDA Pharmaceuticals 59

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 76

Government Compliance FDA Licensing 76

FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

But forty years ago, Al was the generic drug industry’s patent counsel during the negotiations that led to the Hatch-Waxman Amendments. He originated the idea of patent certifications, new drug exclusivity, and the Bolar exemption. (And

Drugs 59

Drugs Pharmaceuticals 59

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 59

FDA Production Marketing Drugs 59

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 64

FDA Regulations Laboratories Government 64

FDA Law Blog: Biosimilars

JULY 2, 2025

Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its regulatory oversight for over-the-counter (OTC) products. By Charles D. Snow — Since the U.S. In this case, we all know the delinquent companies’ names.

Compliance 52

Compliance FDA Production Marketing 52

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 59

Drugs Government 59

FDA Law Blog: Biosimilars

APRIL 27, 2025

is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. By Hyman, Phelps & McNamara, P.C. As a reminder, Hyman, Phelps & McNamara, P.C. to 1:30 p.m. (ET).

FDA 64

FDA Trials Drugs 64

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 69

Testimonials Pharmacy Government Drugs 69

FDA Law Blog: Biosimilars

APRIL 16, 2025

is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. Hull & JP Ellison & John W.M. Claud Hyman, Phelps & McNamara, P.C. to 1:30 p.m. (ET) ET) (register here ).

FDA 59

FDA Trials Drugs 59

FDA Law Blog: Biosimilars

JULY 10, 2025

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database.

FDA 52

FDA Packaging Production Drugs 52

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 59

Pharmacy Therapies Disease Drugs 59

FDA Law Blog: Biosimilars

JUNE 29, 2025

Gibbs — The Federal Food, Drug, and Cosmetic Act (FD&C Act) has very different regulatory regimes for pharmaceutical products than devices. drug, device, biologic, or combination product) and/or review/lead Center (i.e., In 2016, we said that “OCP has earned a reputation for designating products as drugs rather than devices.”

FDA 59

FDA Production Regulations Drugs 59

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.

FDA 59

FDA Drugs Production 59

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Prehearing Ruling (Dec. 4, 2024), at 1.

Testimonials 52

Testimonials Regulations Drugs 52

FDA Law Blog: Biosimilars

JULY 6, 2023

The final rule’s publication is a “high priority”, according to Dr. 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. In fact, the priority designation for the final rule is labeled as “economically significant.”

Regulations 52

Regulations FDA Drugs 52