FDA Law Blog: Biosimilars

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. In fact, federal law and regulation appear to require AbbVie to list these patents.”

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FDA Law Blog: Biosimilars

MARCH 26, 2024

In a seemingly run of the mill patent suit, Teva sued Amneal for infringement of 5 patents arising from the submission of Amneal’s ANDA referencing Teva’s combination product ProAir HFA NDA in fall 2023. Because a “drug product” is defined by regulation as a “Finished dosage form.

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Agency IQ

SEPTEMBER 15, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 11, 2023 6:44 PM CDT Regulatory background: User fees and over-the-counter (OTC) drug reform Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). FDA regulations, at 21 C.F.R. Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling. 355(j)(2)(A)(v).

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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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promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812 (b)(1).

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

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Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC, LAURA DIANGELO, MPH MAY 30, 2023 9:39 PM CDT Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely. “The The FDA recently concluded its work on a proposed rule focused on PMI.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira (adalimumab) loss of exclusivity (LOE) in 2023. Percent on a Reported Basis, or 12.5

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FDA Law Blog: Biosimilars

MAY 21, 2024

29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. Letter to U.S. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

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FDA Law Blog: Biosimilars

MAY 5, 2024

Last August, the Food and Drug Administration (“FDA”) and HHS, after considering the eight-factor analysis required by the Controlled Substances Act (“CSA”) for scheduling substances of abuse, recommended DEA reschedule marijuana from schedule I to schedule III. 29, 2023). Letter to U.S. Letter to President Joseph R. 21 U.S.C. §

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