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

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

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.

Biosimilars 52

Biosimilars Dosage 52

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 Pharmaceutical Manufacturing Drug Pricing 59

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

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.

Dosage 52

Dosage Biosimilars 52

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

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

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

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

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 45

Dosage 45

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

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

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

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 59

Controlled Substances Dosage 59

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

Pharmacy Times

JUNE 17, 2025

A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.

Dosage 26

Dosage Pharmacy Technician Compounding Pharmacies Inpatient 26

Pharmacy Times

JUNE 16, 2025

The biosimilar demonstrated comparable efficacy and safety to Stelara in a phase 3 clinical trial, supporting its FDA approval. Steqeyma provides a new dosage form and strength, enhancing treatment flexibility for young patients with chronic inflammatory conditions. The biosimilar is a 45 mg/0.5

Biosimilars 41

Biosimilars Pharmacy Technician Compounding Pharmacies Immunization 41

PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Supernus Pharmaceuticals Generic Name: Topiramate First Approval Date: Aug 16, 2013 Patent Expiration: Jan 2023 2022 Sales: $261.2M Glenmark has also released its generic drug version in the US market.

Biosimilars 49

Biosimilars Diabetes Chemotherapy Immunization 49

Pharmacy Times

JUNE 13, 2025

In addition, the dosage [of 2000 IU per day] used in the research is far below the target dose for correcting vitamin D deficiency, which is usually 50,000 IU per week,” Carvalho-Pessoa said in a news release. 1,2 “Even with a small sample of participants, it was possible to observe a significant difference in the response to chemotherapy.

Chemotherapy 54

Chemotherapy Pharmacy Technician Immunization Immunity 54

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 Labelling Compounding 52

Pharmacy Times

JUNE 17, 2025

Results American Oncology Network (AON) Pharmacy collected data on waste and cost avoidance from February 2023 to September 2023. If a discrepancy is found, the pharmacy nurses will hold the shipment, and a clinical intervention will be communicated to the provider. During this time frame, the pharmacy documented 152 interventions.

Mail-Order Pharmacies 26

Mail-Order Pharmacies Pharmacy Technician Compounding Pharmacies Inpatient 26

Pharmacy Times

JUNE 10, 2025

1 "[Meloxicam injection] demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," Ron Scarboro, chief executive officer at Azurity Pharmaceuticals, said in a press release. December 21, 2004. Subscribe Now!

Pharmacy Technician 29

Pharmacy Technician HIV Treatment and Prevention Agents Compounding Pharmacies Biosimilars 29

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

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

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

Pharmacy Times

JUNE 16, 2025

The investigators assessed a total of 90 patients who received talquetamab at a dosage of 0.8 mg/kg once every 2 weeks plus teclistamab at a dosage of 3.0 2 As a combination therapy, talquetamab and teclistamab show significant promise in the phase 1b/2 dose escalation and expansion in the RedirecTT-1 trial (NCT04586426).

Pharmacy Technician 20

Pharmacy Technician Compounding Pharmacies Immunization Immunity 20

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 Documentation Biosimilars Hospitals 111

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 69

Controlled Substances Chemotherapy Dosage Labelling 69

Pharmacy Times

JUNE 9, 2025

HME in drug manufacturing typically employs corotated twin extruders and uses heat and pressure to create solid dosage forms, dispersing the active pharmaceutical ingredient within a molten polymer matrix, and forming a solid solution or amorphous solid dispersion. trillion economic impact in 2020.

Pharmacy Technician 29

Pharmacy Technician Compounding Pharmacies Compounding Pharmacy Management 29

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 111

Pharmacy Management Dosage Documentation 111