FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

FDA Approval 40

FDA Approval FDA Production Drugs 40

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” FDA thus disagrees that such differences are not clinically meaningful.

FDA 59

FDA Biosimilars Production Regulations 59

The Pharma Data

JULY 8, 2021

One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The FDA Commissioner is quoted as saying that “[t]he FDA stands ready to assist the FTC.

FDA 105

FDA Drugs Biosimilars FDA Approval 105

The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class.

Treatment 52

Treatment Therapies Disease FDA Approval 52

FDA Law Blog: Biosimilars

MARCH 29, 2023

Last week Harm Reduction Therapeutics announced that it has entered into a commercial supply agreement with Catalent which will manufacture RiVive—if approved—at its facility in Morrisville, North Carolina. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

Pharmacy 105

Pharmacy FDA FDA Approval Production 105

FDA Law Blog: Biosimilars

JUNE 13, 2024

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug.

FDA 116

FDA FDA Approval Production Drugs 116

FDA Law Blog: Biosimilars

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.”

FDA Approval 59

FDA Approval FDA Hospitals Regulations 59

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program.

Science 40

Science Biosimilars FDA Production 40

FDA Law Blog: Biosimilars

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list.

Science 81

Science FDA Approval FDA Drug Development 81

Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. FDA approved 13 NMEs through the AA pathway in FY 2023, making up 25.5%

FDA 52

FDA Biosimilars Science Drugs 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA has not approved an NDA for a drug containing botanical marijuana but notes that two drug products containing delta-9-tetrahydrocannabinol (“delta-9-THC”) (as dronabinol), the primary compound in marijuana have received FDA approval: Marinol and Syndros. chemotherapy-induced), and pain.

FDA 69

FDA FDA Approval Treatment Drugs 69

FDA Law Blog: Biosimilars

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

Small Molecule 102

Small Molecule Government FDA Approval Regulations 102

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Pipeline Information. billion.

FDA 52

FDA Production Biosimilars FDA Approval 52

FDA Law Blog: Biosimilars

OCTOBER 1, 2024

FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending ( Motion to Dismiss Denied-in Part/Granted-in-Part ) 1:2023cv02884 (D.D.C.)

Government 59

Government FDA Pharmaceuticals FDA Approval 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

FDA Approval 59

FDA Approval FDA Production Therapies 59

FDA Law Blog: Biosimilars

MAY 11, 2023

If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.”

Government 72

Government FDA FDA Approval Doctors 72

FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

His unique background underscores his remarkable expertise as a cochlear implant researcher, a former FDA regulator, and his current role as a device attorney. The comprehensive agenda for the symposium can be accessed in its entirety here.

Science 52

Science FDA Approval FDA Regulations 52

The Pharma Data

MAY 2, 2022

AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area.

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

The Pharma Data

JUNE 24, 2021

Talazoparib is currently approved under the brand name TALZENNA ® for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Selection of patients for therapy is based on an FDA-approved companion diagnostic for TALZENNA.

Clinical Trials 52

Clinical Trials DNA Trials Treatment 52

FDA Law Blog: Biosimilars

APRIL 21, 2024

Usually at this point in a post we would identify the date of approval of the relevant NDA. But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ?

FDA 59

FDA FDA Approval Production Marketing 59

FDA Law Blog: Biosimilars

APRIL 30, 2023

1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. That bill is S.

FDA 59

FDA Biosimilars Regulations FDA Approval 59

FDA Law Blog: Biosimilars

JANUARY 4, 2024

HPM is ably represented by seasoned drug product development and authorization attorney—and former FDA counsel— Deborah Livornese. Deb assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.

Compliance 52

Compliance FDA FDA Approval Drugs 52

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

Biosimilars 40

Biosimilars FDA Production Treatment 40

FDA Law Blog: Biosimilars

MARCH 26, 2024

Very clearly, the brief states “In the FTC’s view, device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing , and a device patent that is improperly listed in the Orange Book must be delisted” (emphasis added).

FDA 59

FDA Production FDA Approval Drugs 59

FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners.

Regulations 59

Regulations Pharmacy Licensing Licensing 59

FDA Law Blog: Biosimilars

MAY 15, 2023

The AAFCO OP includes FDA approved feed and color additives, substances that are subject to GRAS notifications (AGRNs), etc. Most states treat the OP as a “positive list” of ingredients that may be included in animal foods.

Regulations 45

Regulations FDA Approval FDA Production 45

FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2.

FDA 52

FDA FDA Approval Licensing Licensing 52

FDA Law Blog: Biosimilars

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

FDA 59

FDA Regulations FDA Approval Drugs 59

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.

FDA 45

FDA Drugs FDA Approval Packaging 45

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

FDA 59

FDA Production FDA Approval Licensing 59

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The user fee program for OTC drugs is relatively young. Read AgencyIQ analysis here.]

FDA 40

FDA Government Drugs Production 40

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Trials Disease 52

FDA Law Blog: Biosimilars

AUGUST 16, 2023

As part of the Warning Letter, OPDP states, “To date, no drug has been shown to improve ACM in COPD” and includes a footnote that states, “Through the issuance of this letter, FDA does not intend to convey any views on whether data that did show that Breztri improved ACM in COPD would support a change to the FDA-approved labeling for Breztri.”

FDA 52

FDA FDA Approval Treatment Drugs 52

FDA Law Blog: Biosimilars

MARCH 12, 2024

And, in fact, FDA muddied the waters itself when it stated in the 2003 implementing regulation preamble that “patents claiming devices or containers that are ‘integral’ to a drug product or require prior FDA approval should be submitted and listed” and noting that patents claiming a finished dosage form of a product, which include “metered aerosols, (..)

Drugs 45

Drugs FDA Regulations FDA Approval 45

FDA Law Blog: Biosimilars

JULY 24, 2023

Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

FDA 52

FDA Regulations Clinical Trials Drugs 52