FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Spanogle, Ph.D.

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Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). Consent Agreement and Final Judgment ¶ 10.a.-n.

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP).

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. We have drafted a memorandum that summarizes the main provisions of this proposed rule and notes where the regulation differs from the guidances.

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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

MARCH 24, 2024

Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation. Code Ann. § McClain , No.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Palmer , Larry K. Houck , and Kalie E.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

OCTOBER 27, 2020

Reddy’s”) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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FDA Law Blog: Biosimilars

APRIL 16, 2024

Vanda Pharmaceuticals, Inc. Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. We wrote a memorandum summarizing CMS’ regulation here. Vanda Pharmaceuticals, Inc. 23-1457 (4th Cir.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. pharmaceutical law ceased to apply to the U.K. from the E.U.

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FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. The evolving upswing in NDSRI regulation is due to their link to cancer. Koblitz — We need to talk about nitrosamines.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C.

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The Pharma Data

MARCH 5, 2021

At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. “We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement. The facts are detailed in the complaint.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

Vanda Pharmaceuticals, Inc. Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations. See our memo summarizing CMS’s regulation here. MJM-22-977 (Dist.

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FDA Law Blog: Biosimilars

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form.

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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing. See Order at 15, 21.

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Agency IQ

SEPTEMBER 22, 2023

patient, caregiver) in the use of their medications (including both pharmaceuticals and biological products) would be considered PDURS. The FDA regulates both product labeling ( 21 CFR 201 ) and promotional labeling ( 21 CFR 202 ). In effect, technologies like a mobile health app that is intended to support a user (e.g.,

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. Dormer (Hall of Fame), Jeffrey N. Gibbs (Hall of Fame), John A. Gilbert , Gail H.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ). Taiho Oncology, Inc.)

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The Pharma Data

JANUARY 24, 2021

The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. The FTD is designed to make important new drugs accessible to patients faster.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 28, 2023 12:13 AM EDT Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., The FDA regulates prescription drug advertising under 21 CFR 202.1 , Prescription drug advertisements.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA regulations, at 21 C.F.R. As such, Vanda’s citizen petition stated that these approvals are “clearly erroneous under the FDCA and agency regulations and will put. Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

The Guidance which is the subject of this blogpost specifically provides that it is applicable to facilities which manufacture either generic drugs or active pharmaceutical ingredients for generic drugs. The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. ALEXION PHARMACEUTICALS, INC. ALEXION PHARMACEUTICALS, INC. Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences. Raised full year guidance, driven by increased revenue guidance of $350 million. BOSTON –(BUSINESS WIRE)–Oct.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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