FDA Law Blog: Biosimilars

JUNE 1, 2025

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture. flip the Health & Economy piece on the NIH website.)

Pharmaceutical Companies

FDA Law Blog: Biosimilars

MAY 27, 2025

How many will be present in each meeting? Here are some of the unanswered questions: Is this a listen-only tour? Should executives expect to hear answers to their questions? How will industry participants be chosen? Is there a lottery? Will topics need to be submitted ahead of time? Will the meeting discussion be made public?

FDA

FDA Law Blog: Biosimilars

APRIL 8, 2025

For example, DPD worked with subject matter experts from across FDA to clarify the scientific and regulatory pathway for the transition of generic metered-dose inhalers to different propellants, and presented publicly on this topic in December 2024. But thats all in the past now.

FDA

FDA Law Blog: Biosimilars

MAY 15, 2025

is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connectsannual Life Sciences Pricing & Contracting USA Summit , which is being held virtually and in-person in Philadelphia on May 19-21. Hyman, Phelps & McNamara, P.C.

Science

FDA Law Blog: Biosimilars

JUNE 3, 2025

DEAs position is contrary to statements made in the agencys 2024 Coconut Grove decision when its expert opined at the hearing that filling immediate-release opioids prescribed and dispensed over a period of one and a half to two years presented red flags and [the pharmacy] needed to properly resolve these red flags before dispensing.

Pharmacy

FDA Law Blog: Biosimilars

MARCH 6, 2025

A series of recent cases has held that, unless there is evidence that the President wants to remove an official but cannot do so because of statutory limitations on his power, there is no judiciable harm presented. Barlow-Ahsan v. Kijakazi , 2023 U.S. LEXIS 185877, at *24-25 (E.D. 17, 2023) (citing cases).

Government

FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Date: Wednesday, December 11, 2024 Time: 12:00 PM to 1:15 PM ESTfda Presenters: Alan Kirschenbaum , Director, HPM Jennifer Lospinoso, Managing Director, Riparian LLC Lynn Buhl, Managing Director, Riparian LLC Please click here to register. Once you register, youll receive instructions by email on how to access the webinar.

Drugs

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

Webinar Details: Date: Tuesday, February 18, 2025 Time: 12:00 PM to 1:30 PM ET Presenters: Alan Kirschenbaum , Director, HPM Sophia Gaulkin , Associate, HPM Cynthia Hwang, General Manager, Riparian LLC Susan Dunne, Managing Director, Riparian LLC Please click here to register.

Drugs

FDA Law Blog: Biosimilars

APRIL 22, 2025

Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence. The hearing closely resembles a trial, but the ALJ (rather than a jury) is the trier of fact. Hearings can range from half a day to several weeks, depending on the complexity of the case.

Testimonials

FDA Law Blog: Biosimilars

FEBRUARY 12, 2025

However, at a House Energy and Commerce Committee hearing last September, the director of FDAs Center for Tobacco Products stated that FDA has not abandoned the menthol product standardits presently with the White House and continues to be a priority for us.

FDA

Drug Patent Watch

MARCH 31, 2025

The market presents numerous opportunities for growth, including expanding into emerging markets and developing more complex generic medications. Regulatory hurdles, intellectual property disputes, and quality control issues are key challenges facing the market.

Marketing

DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

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

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

FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation.

Biosimilars

The Pharma Data

MAY 26, 2023

Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.

Biosimilars

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

The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. An archived version of the webinar will be available following the presentation. About Biogen.

Licensing

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

Biosimilars

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

Biosimilars

FDA Law Blog: Biosimilars

JUNE 25, 2024

Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. But, as time has marched on and FDA’s experience with interchangeable biosimilars grown, the Agency’s “experience has shown that.

Biosimilars

Drug Channels

OCTOBER 7, 2024

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions: What are the latest legislative updates and proposed federal bills impacting PBM operations? You’ll hear from Matthew Gibbs, Pharm.D., And much more !

Pharmacy

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

FDA

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

FDA Law Blog: Biosimilars

JUNE 24, 2024

HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. Since its inception, the Format has been instrumental in standardizing the submission process, ensuring that critical data is presented in a clear and consistent manner.

Pharmaceuticals

Drug Channels

JULY 11, 2022

Harness data-driven tech offerings to combat the urgent public health crisis and provide patients and stakeholders with unrivaled support services in an all-encompassing state-of-the-art hub.

Specialty Pharmacies

The Pharma Data

MAY 4, 2021

The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March. . Posted 04 May 2021 | By Michael Mezher .

Science

FDA Law Blog: Biosimilars

AUGUST 14, 2023

Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. By Douglas B.

FDA

The Pharma Data

JUNE 25, 2021

An archived version of the webcast will be available following the presentation. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.

Biosimilars

The Pharma Data

MARCH 22, 2021

An archived version of the webcast will be available following the presentation. To access the live webcast, please visit Biogen’s Investors section at www.investors.biogen.com. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

Biosimilars

The Pharma Data

SEPTEMBER 1, 2021

An archived version of the webcast will be available following the presentation. The webcast will be live on Thursday, September 9, at 9:30 a.m. To access the live webcast, please visit Biogen’s Investors section at investors.biogen.com. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

Biosimilars

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The HCF formulation is presented in the same auto-injector as currently available to patients, aiming for an enhanced yet familiar patient experience.

Biosimilars

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

Compliance

The Pharma Data

NOVEMBER 10, 2020

Michael Yu , the founder, Chairman and CEO, attended and presented on the virtual R&D day via live video webcast. During the introduction presentation, Dr. Michael Yu reviewed the history and achievements in the past nine years since the establishment of Innovent.

Biosimilars

FDA Law Blog: Drug Discovery

DECEMBER 20, 2023

Then, in early 2023, CDER and CBER started a slow phase-in of in-person meetings in a hybrid format, with some attendees present only virtually. At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings.

FDA

Eye on FDA

FEBRUARY 10, 2021

Heightened Role for “Bad Ad Program” – A recent interview with the new Acting Director of OPDP revealed that a primary focus for the office this past year was in relation to the biosimilars market. Nothing about risk presentation on mobile sites. The agenda still has a focus on DTC print and television ads.

FDA

DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. The high costs associated with bringing a new drug to market, estimated to be over $2.6

Pharmaceuticals