FDA Law Blog: Biosimilars

MARCH 24, 2025

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Marijuana would also remain subject to applicable provisions of the Food, Drug and Cosmetics Act.

Regulations

FDA Law Blog: Biosimilars

JULY 23, 2025

Food and Drug Administration (FDA). In that role, he led and supported the agency’s litigation efforts in high-stakes matters involving drug approvals, exclusivity disputes, enforcement actions, and administrative law challenges. He also provides strategic litigation support and proactive counsel on agency engagement.

Government

FDA Law Blog: Biosimilars

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection.

FDA

FDA Law Blog: Biosimilars

JUNE 4, 2025

What might that look like for the drug sector? This overprescribing relates to a lack of long-term data for either safety (particularly neurodevelopmental) and efficacy for drugs which are nevertheless often prescribed long-term. That leaves us to speculate what the implications of this Assessment will be.

Drugs

Drug Patent Watch

APRIL 8, 2025

Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Evaluate the number of products in development, their potential market size, and the competition. Regulatory Environment : Changes in regulatory policies can impact a company's valuation.

Pharma Companies

FDA Law Blog: Biosimilars

MAY 4, 2025

Houck Drug Enforcement Administration (DEA) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. By Larry K. On March 26th the U.S.

Packaging

FDA Law Blog: Biosimilars

NOVEMBER 19, 2024

But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FDA is already facing a massive inspectional backlog. We would say certainly not, as it underscores a critical need to ensure drug safety and efficacy.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? 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).

Government

The Pharma Data

JUNE 6, 2025

As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Although not altogether surprising, the formality of an official announcement still came as a shock to many of us who work in areas regulated by HHS, as well as to many others in the public health arena. The first point he made pertained to reforming the Prescription Drug User Fee Act (PDUFA).

FDA

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. Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. In 2021, the U.S.

Drugs

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The conference equips legal professionals without prior regulatory experience, as well as life sciences executives involved with FDA-regulated products, with a comprehensive understanding of fundamental FDA principles. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products.

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

FDA Law Blog: Biosimilars

JUNE 30, 2025

The Federal Controlled Substances Act (“CSA”) and its regulations require Drug Enforcement Administration (“DEA”) registrants to submit certain reports related to narcotic drug transactions, thefts and significant losses, and suspicious orders. 21 U.S.C. § 827(d)(1); 21 C.F.R. Code 4729:8-3-04. 16, § 1782; Ga. Code Ann. §

Pharmacy

FDA Law Blog: Biosimilars

JUNE 2, 2025

As HPM argued in both the groundbreaking citizen petition Jeffrey Gibbs filed thirty-two years ago and the papers we filed on behalf of our clients, Dr. Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices.

FDA

FDA Law Blog: Biosimilars

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. FOIA is a U.S.

FDA

FDA Law Blog: Biosimilars

MAY 15, 2025

Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Weve been poisoning them and drugging them at scale. By John W.M. Claud & Deborah L.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

As weve previously blogged, a PCCP is a mechanism established by Congress under the Food and Drug Omnibus Reform Act (FDORA) to streamline post-market changes to medical devices. Therefore, this guidance builds on FDAs commitment to develop and apply innovative approaches to the regulation of [AI-enabled devices].

FDA

FDA Law Blog: Biosimilars

JULY 13, 2025

What This Means for Industry For FDA-regulated sectors—including pharmaceuticals, medical devices, food safety, and cosmetics—this convergence of executive and judicial action could have immediate and longer-term consequences such as regulatory delays or disruptions.

FDA

FDA Law Blog: Biosimilars

MARCH 31, 2025

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. And Congress vested authority over those regulations in CMS, not in FDA.

Laboratories

FDA Law Blog: Biosimilars

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. Andrew Hull brings his expertise to the firms enforcement, compliance, and litigation practice.

Nurses

FDA Law Blog: Biosimilars

MARCH 23, 2025

Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 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. Its already been a long time coming.

FDA

BioPharma Drive: Drug Pricing

SEPTEMBER 20, 2023

The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.

Biosimilars

FDA Law Blog: Biosimilars

APRIL 22, 2025

If you decide to request a hearing, DEAs revised hearing regulations require that you simultaneously file an Answer to the Order to Show Cause. A third option is to ignore the Order to Show Cause, in which case DEA will request a final order based only on DEAs evidence.

Testimonials

FDA Law Blog: Biosimilars

MARCH 12, 2025

Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S. 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.

FDA

BioPharma Drive: Drug Pricing

JUNE 28, 2024

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

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

Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

Biosimilars

Drug Channels

DECEMBER 17, 2020

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Drug pricing perceptions always seem to lag reality. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise.

Biosimilars

FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

FDA

The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

Biosimilars

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

Hospitals that fail to fulfill their obligations under the federal Controlled Substances Act and DEA regulations pose serious health risks to patients for undertreatment and worse, and to employees for overdose and death. Employee diversion can also result in unwanted local and national publicity.

Hospitals

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.

Biosimilars

ProRelix Research

NOVEMBER 23, 2022

Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […]. The post Biosimilar Clinical Trials and US FDA Guidance appeared first on ProRelix Research.

Clinical Trials

FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

Regulations

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

FDA