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 59

Dosage 59

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 59

Dosage 59

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 105

Communication Dosage Biosimilars 105

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

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 59

Dosage 59

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 59

Inpatient Hospitals Dosage Controlled Substances 59

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

European Pharmaceutical Review

SEPTEMBER 26, 2023

The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Sandoz has the rights to commercialise and distribute it in all markets under the deal.

Biosimilars 59

Biosimilars Dosage Packaging 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

Dosage 59

Dosage Drug Pricing Pharmaceutical Manufacturing 59

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.

Biosimilars 52

Biosimilars Dosage Compounding Labelling 52

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

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 59

Dosage 59

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

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

Dosage 64

Dosage Drug Pricing 64

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 69

Controlled Substances Chemotherapy Compounding Dosage 69

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.

Dosage 111

Dosage Biosimilars Documentation Hospitals 111

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

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

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 95

Controlled Substances Chemotherapy Dosage Labelling 95