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. Jazz believes that FDA precedent precludes that position and thus FDA departed from established policy, which FDA denied ever existed.

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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. In short, all studies found no significant difference between phenylephrine and placebo.

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Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Therapeutics There are no FDA-approved therapies built upon Cas12, but the enzyme is currently being used in multiple clinical trials.

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The Pharma Data

DECEMBER 17, 2020

BENLYSTA is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease,” said GSK Chief Scientific Officer and President of R&D Dr. Hal Barron. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

MAY 5, 2021

Ferriprox was originally approved in 2011 as a therapy for patients with transfusional iron overload due to thalassemia syndromes for whom chelation therapy was not adequate. .

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The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

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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.” Plainly, the Government brief states “The decision below is incorrect.

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Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. The drugs work by blocking a protein, PD-1 — which helps keep immune responses in check — and stimulating the immune system to attack tumors.

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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Nature 477 , 220–224 (2011). Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023. DOI: 10.1101/2023.02.07.23285407. Ochoa D, Karim M, Ghoussaini M, Hulcoop DG, McDonagh EM, Dunham I. Nat Rev Drug Discov. 2022 Aug;21(8):551. PMID: 35804044.

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Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability.

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The Pharma Data

SEPTEMBER 8, 2021

On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

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Agency IQ

OCTOBER 6, 2023

Earlier this year, the FDA reported that, for FY 2021, 31% of all required post-marketing studies had not yet been completed and were off-schedule for future completion. Despite the growing controversy, the number of products granted accelerated approval increased in FY 2023. of all NME approvals this year.

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The Pharma Data

AUGUST 17, 2021

On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

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The Pharma Data

OCTOBER 25, 2020

FDA approval. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder.

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The Pharma Data

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”

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The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. WHAT IS XARELTO ® (rivaroxaban)?

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The Pharma Data

DECEMBER 21, 2020

2011:29;2121-27. Related Articles: Tagrisso (osimertinib) FDA Approval History. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tax Petition. In July 2021, we filed a petition in the U.S.

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The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. In 2011, through a collaboration agreement with Ono Pharmaceutical Co.,

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The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. In 2011, through a collaboration agreement with Ono Pharmaceutical Co.,

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. ZYTIGA ® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), approved by the U.S.

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Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

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Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

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Codon

AUGUST 26, 2024

In 2011, research groups at the MIT Lincoln Laboratory and Boston University fused together two different proteins to make broad antivirals: one protein binds to double-stranded RNA, and the other triggers apoptosis, or cell death. As a result, it is classified as a “drug-free” product and does not require FDA approval.

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New Drug Approvals

APRIL 27, 2025

13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] January 2011. billion in 2004. [23]

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New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Jump up to: a b c d e f g h i j k “FDA approves imaging drug for evaluation of myocardial ischemia” U.S. Food and Drug Administration (FDA). mmol) and Na 2 CO 3 (0.33

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New Drug Approvals

MAY 11, 2025

. ^ Jump up to: a b c d e f g h i j k l m n o p q “FDA approves first treatment for Friedreich’s ataxia” U.S. Food and Drug Administration (FDA). July 2011). 28 February 2023. Archived from the original on 1 March 2023. Retrieved 28 February 2023. 306 (5): 447454. doi : 10.1007/s00403-013-1433-7.

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LifeSciVC

MAY 28, 2025

Further, the pace of fast follower drugs is striking relative the past: according to PhRMAs recent report on innovation , the average time for a drug class to have three FDA approvals in it went from ~15 years in 1990-2003 to ~2 years in 2013-2021. Started in 2011, before Lyft, ended up shutting down in 2015.

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Broad Institute

NOVEMBER 6, 2024

Kerry Reynolds: The first immune checkpoint inhibitor was FDA-approved in 2011 to treat melanoma, with nearly a dozen more ICIs approved for various cancers since then. How big of a problem are these complications from cancer immunotherapy? These are home-run, breakthrough therapies, and quite an amazing success story.

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Codon

JANUARY 26, 2025

Even in good years, such as 2010-2011, the vaccine tops out at about 60 percent efficacy. There is only one FDA-approved intranasal vaccine for any disease: the FluMist Quadrivalent flu vaccine, which uses weakened forms of viruses to trigger an immune response. After nearly a century , influenza vaccines remain hit-or-miss.

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Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. See 2023 Mich.

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Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

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Drug & Device Law

NOVEMBER 2, 2023

Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. The defendant in Zyla is a qualifying compounding pharmacy that sells without FDA approval a compounded product containing the active ingredient found in the plaintiff manufacturer’s FDA-approved product. Mukasey , 536 F.3d

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Drug & Device Law

SEPTEMBER 22, 2023

604 (2011), and Mutual Pharmaceutical Co. 379r(e) product liability savings clause Id. at 1283-87. The second is that OTC monographs impose federal requirements—including labeling requirements—on the drugs they cover, and manufacturers are not free to unilaterally change them. As a result, implied preemption derived from PLIVA, Inc.

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Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. We—truly in the plural sense—will continue to trash bad decisions and amplify good decisions in our little niche of the legal world. Mensing , 564 U.S.

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Drug & Device Law

JULY 24, 2023

To put that in context, the Actos label also carries the FDA’s most serious type of warning – a boxed warning – but for congestive heart failure, not bladder cancer. precipitously” after the 2011 label change adding the bladder cancer language, a “significant number” of claims would not have been reimbursed by TPPs nationwide.

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