FDA Law Blog: Biosimilars

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., Vanda Pharmaceuticals, Inc. MJM-22-977 (Dist.

Dosage 57

Dosage 57

Pharmaceutical Technology

MAY 26, 2023

On 18 May 2023, the FDA announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers.

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Dosage Biosimilars 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.

Pharmacy Management 108

Pharmacy Management Dosage Documentation 108

FDA Law Blog: Biosimilars

MARCH 12, 2024

As we explained in September 2023 , then again in November 2023 , the FTC has intervened in the matter and asked 10 drug companies (really 8 given common ownerships of some of the relevant companies) to delist about 100 patents from the Orange Book that mainly cover the device constituent of a drug/device combination product.

Dosage 57

Dosage 57

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. Teva’s patents do not meet that criterion.

Dosage 57

Dosage 57

FDA Law Blog: Biosimilars

JULY 1, 2024

The request for hearing follows a n October 2023 letter preceding the NPRM from six former Administrators and five former Directors of National Drug Policy. The Department of Justice reviewed Health and Human Services’ August 2023 re scheduling recommendation and conducted a separate review of the eight factors. 21 U.S.C. §

Dosage 52

Dosage Controlled Substances 52

FDA Law Blog: Biosimilars

JULY 31, 2023

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. codified at 21 C.F.R. b)(5)(ii)).

Controlled Substances 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

Communication 104

Communication Dosage Biosimilars 104

FDA Law Blog: Biosimilars

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 823(g)(1).

Controlled Substances 52

Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R. covering ANDA Suitability Petitions.

Dosage 57

Dosage 57

FDA Law Blog: Biosimilars

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. 16 June 2023) Eliquis Novartis D.N.J. (1

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Dosage Drug Pricing 62

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). Complaint ¶ 57. (The

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

AUGUST 14, 2023

Other interesting datapoints from her presentation: For the period from FY2000 to May of 2023, the percentages of drug manufacturing inspections with OAI classifications was lower in China (about 5% of inspections) than in the United States (8%). facility inspections are approaching traditional levels.

Dosage 52

Dosage Compounding 52

FDA Law Blog: Biosimilars

APRIL 8, 2024

In addition, DEA apportions individual manufacturing quota to API manufacturers and procurement quotas to dosage form manufacturers, which also limits how much each company can manufacture. For example, DEA and FDA jointly acknowledged in an August 1, 2023 letter that there have been ongoing shortages of various stimulant medications (e.g.,

Inpatient 57

Inpatient Hospitals Dosage Controlled Substances 57

Pharmaceutical Technology

NOVEMBER 3, 2022

The Australian Department of Health and Aged Care published a similar statement on August 25, stating that tenecteplase shortages will likely affect the country until the end of 2023. But since these generics or biosimilars are often not too profitable, manufacturers require incentives, say Beavers and Page. Improving the supply chain.

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Dosage Biosimilars Documentation Hospitals 111

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.

Controlled Substances 67

Controlled Substances Chemotherapy Compounding Dosage 67

PharmaState Academy

MAY 16, 2023

Over the next 15 to 20 years, you can expect pharma business models of today to be metamorphosed by biopharmaceuticals and biosimilars. PFS are ready to use disposable syringes containing premeasured dosage of the medicine. Biopharma technologies will develop new ways to treat and cure a wide range of diseases. And the biggest benefit?

Biosimilars 52

Biosimilars Dosage Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

AUGUST 8, 2024

In the most recent eight factor analyses prior to August 2023, in 2016 HHS and DEA concluded that marijuana continued to meet criteria for remaining in schedule I. Schedule I substances have a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lack accepted safety for use under medical supervision.

Controlled Substances 57

Controlled Substances Dosage 57

PharmaShots

APRIL 26, 2023

The report is concluded with an engaging SWOT analysis and edifying KOL reviews Active Ingredient: Dupilumab Dosage Forms & Strengths: Single-Dose Pre-Filled Syringe with Needle Shield Injection: 300 mg/2 mL, 200 mg/1.14 PharmaShots' analysis of Dupixent’s clinical trials is depicted below: (Trials were taken on 29 Mar 2023).

Biosimilars 56

Biosimilars Dosage 56

Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. JAMP’s product was the eighth adalimumab biosimilar to come to market in Canada. A-203-22). mL presentation.

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Biosimilars Dosage 52

Pharma in Brief

NOVEMBER 5, 2023

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. Requirements for obtaining a listing are set out in O.

Dosage 52

Dosage Biosimilars 52

Pharma in Brief

JANUARY 25, 2023

We also flag what to watch out for in 2023. The most significant legislative changes concerned the Patent Act and accompanying rules/regulations. It remains to be seen how these changes will impact patent prosecution strategy in the pharmaceutical sector in 2023.

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Biosimilars Dosage Compounding Labelling 52

FDA Law Blog: Biosimilars

MAY 21, 2024

DEA further believes that factual evidence (including scientific data) and expert opinions with additional data on different forms, formulations, delivery methods, dosages, and concentrations “may be relevant.” 29, 2023) (“Basis”); NPRM at 44,603. The eight factors with a summary of relevant findings follow.

Controlled Substances 67

Controlled Substances Chemotherapy Dosage Labelling 67

PharmaShots

JUNE 28, 2023

PharmaShots' analysis of Enbrel’s industry trials is depicted below: (Trials were taken on 6 Jun 2023). The chart depicts data till 8th Jun 2023). Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. This list is not an exhaustive list.

Biosimilars 40

Biosimilars Insurance Coverage and Processing Dosage Compounding 40

FDA Law Blog: Biosimilars

MAY 5, 2024

29, 2023). FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. Unlike its 2016 analysis, FDA’s/HHS’ 2023 analysis considers marijuana to have a currently accepted medical use in treatment in the U.S. Letter to U.S.

Controlled Substances 94

Controlled Substances Chemotherapy Dosage Labelling 94