Big Molecule Watch

AUGUST 20, 2024

On July 25, 2024, the FDA published a notice establishing a public docket for commenting to obtain information to assist the FDA in assessing how best to advance the development of new biosimilar products, as part of the Biosimilar Use Free Amendments of 2022 (“BsUFA III”). For the time being, the FDA asks two questions.

Biosimilars 45

Biosimilars Documentation 45

Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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Biosimilars Communication Labelling Documentation 49

Big Molecule Watch

NOVEMBER 18, 2024

On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024.

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Biosimilars Documentation 49

Big Molecule Watch

OCTOBER 14, 2024

On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA. Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024.

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Biosimilars Documentation 64

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.

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Documentation 119

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.

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Documentation Packaging 59

FDA Law Blog: Biosimilars

JUNE 10, 2024

Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. Comments on the draft guidance can be submitted to the docket by August 5, 2024. Provide a method of verifying or monitoring the effectiveness of the actions.

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Communication Documentation 111

FDA Law Blog: Biosimilars

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

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Documentation 105

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.

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Documentation Labelling Communication 105

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

4, 2024), at 1. The parties have noticed their intentions to offer into evidence documents they identified in their prehearing statements and must serve each other with a copy of the documents noticed in their prehearing statements no later than January 3, 2025. Prehearing Ruling (Dec.

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Controlled Substances Documentation 52

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.

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Medical Records Documentation 111

Big Molecule Watch

JANUARY 5, 2024

Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. The proposed schedule also provides dates for document discovery and depositions.

Packaging 49

Packaging Biosimilars Documentation 49

Big Molecule Watch

JULY 22, 2024

On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines. requesting data and documents regarding their business and business practices. OptumRx, Inc.;

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Independent Pharmacies Biosimilars Documentation Labelling 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 59

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

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Documentation Packaging Clinical Pharmacology Drug Development 59

FDA Law Blog: Biosimilars

AUGUST 18, 2024

In effect, these documents serve as road signs helping to direct new market entrants. The agency has done far better in posting 510(k) summaries, which are similar types of documents. The same cannot be said for De Novos from January or February.

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Hospitals Documentation 69

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

Big Molecule Watch

JUNE 4, 2024

On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program.

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Documentation Communication Biosimilars 53

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.

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Dosage Biosimilars Documentation Hospitals 111

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.

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Documentation 40

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Documentation Drug Development 64

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

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

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. 50,372 , 50,377 (June 13, 2024). Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 at 50,372-73.

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Controlled Substances Dosage Documentation 52

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

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Drug Development Biosimilars Documentation Labelling 103

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.

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Documentation 59

FDA Law Blog: Biosimilars

OCTOBER 2, 2024

As a reminder, a PCCP is a document submitted in a marketing application that describes future modifications to a device that would typically require submission of a subsequent application and a description of how the sponsor will verify and validate the modified device. Draft Guidance at 4.

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Documentation Hospitals 59

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

As an example, we filed a 513(g) request in December 2024. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information.

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Documentation Labelling 69

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. Yet another rejection was a proposal requiring a diagnosis on Medicaid prescriptions as a condition for claims payment. The most noteworthy are the following: 1.

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Vaccines Inpatient Packaging Documentation 59

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

Pharma in Brief

JANUARY 10, 2024

We also flag what to watch out for in 2024. Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. Draft regulations are expected to be released for consultation in 2024.

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Drug Pricing Documentation Biosimilars Vaccines 52

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.

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Biosimilars Documentation 130

FDA Law Blog: Biosimilars

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents.

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Drug Development Communication Documentation Labelling 59

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.

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Biosimilars Documentation 59

FDA Law Blog: Biosimilars

DECEMBER 2, 2024

The ISO 10993-1: 2018 standard, in turn, describes contact duration as the cumulative sum of single, multiple, or repeated duration of contact, although we are aware that a draft version of the standard (ISO/DIS 10993-1:2024) may be heading in a similar direction to the draft guidance.

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Documentation 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. By Deborah L.

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Pharmacy Management Dosage Documentation 111