FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Documentation 119

Documentation 119

FDA Law Blog: Biosimilars

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. Complete a Site Visit Agenda ( Sample Site Visit Agenda ). Identify the site visit duration. Most common are one- or two-day site visits.) Indicate ability to host a virtual site visit.

Documentation 40

Documentation 40

FDA Law Blog: Biosimilars

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. This guidance, when finalized, will replace the original version of this document finalized in 2017. Patients that use ESD undergo continuous 24/7 monitoring.

Medical Records 111

Medical Records Documentation 111

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Draft Guidance Finally, as part of MDUFA V , FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024.

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Documentation Communication 45

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B.

Documentation 105

Documentation Labelling Communication 105

Pharma in Brief

FEBRUARY 13, 2024

BYOOVIZ (ranibizumab) was approved as a biosimilar equivalent to another Novartis drug used for treating wet AMD, LUCENTIS. Link to decision Novartis AG v Biogen Inc , 2024 FC 52 Samsung Bioepis Co, Ltd. and Biogen Inc., At the time of this decision, Biogen Inc. had a pending trademark application for BYOOVIZ (application no.

Biosimilars 59

Biosimilars Documentation 59

FDA Law Blog: Biosimilars

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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Drug Pricing Biosimilars Dosage Documentation 45

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA’s February 23, 2024 decision says that “the grounds for withdrawing approval have been met because: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use.

Documentation 59

Documentation 59

Safe Biologics

APRIL 11, 2024

by Michael Reilly, ASBM Executive Director The Biden Administration’s FY25 Budget, unveiled on March 11, 2024, takes aim at prescription drug costs but misses the mark and hurts rather than helps patients. and Europe alike, prescribers can already substitute any biosimilar for its reference product. First: in the U.S.

Biosimilars 130

Biosimilars Documentation 130

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024. The next document in the docket is a letter from Dr. Marks referring to an upcoming October 2, 2023, joint (virtual) meeting with CDER and Oncopeptides. Tobolowsky & Michelle L. On August 4, 2023, Oncopeptides submitted its appeal.

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Documentation Labelling Drug Development 59

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.

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Labelling Packaging Documentation 59

Big Molecule Watch

MARCH 1, 2024

As background: the IRA defines “qualifying single source drugs” as drugs that are, among other things, (a) approved or licensed under the NDA or BLA provisions of the FDCA or BPCIA and (b) not the reference product for any generic or biosimilar that is “approved and marketed” (or “licensed and marketed”) pursuant to an ANDA or aBLA.

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Biosimilars Drug Pricing Dosage Documentation 57

Pharmaceutical Technology

NOVEMBER 3, 2022

According to the agency, shortages of both drugs are expected to last until 2024, as a result of growing demand. But since these generics or biosimilars are often not too profitable, manufacturers require incentives, say Beavers and Page. Improving the supply chain. Extending the shelf-life is also a consideration.

Dosage 111

Dosage Biosimilars Documentation Hospitals 111