FDA Law Blog: Biosimilars

JUNE 25, 2025

The proposed order is intended to significantly simplify the development of new dosage forms for oral monograph order drugs that, at this time, may be marketed only in tablets or capsules.

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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.

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Pharmaceutical Commerce

JANUARY 31, 2025

Celltrions Avtozma has been indicated for the treatment of giant cell arteritis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, systemic juvenile idiopathic arthritis, and COVID-19in the same dosages and formulations as its tocilizumab reference product.

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Biosimilars Dosage 59

Big Molecule Watch

AUGUST 2, 2024

On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.” made to licensed biosimilars and licensed interchangeable biosimilars.” regarding postapproval manufacturing changes.

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Pharmacy Times

MARCH 5, 2025

Adalimumab biosimilars differ from adalimumab in approved indications, concentration and dosage, and formulation.

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Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

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Labelling Biosimilars Adverse Reactions Dosage 49

Pharmaceutical Business Review

JULY 3, 2023

mL dosage. Sandoz has a long history of developing and marketing biosimilars that generate healthcare savings and enhance competition that drives innovation in the market.” The post Sandoz makes available biosimilar of Humira in US appeared first on Pharmaceutical Business review.

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Express Pharma

MAY 22, 2024

Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”

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Pharmaceutical Technology

MAY 19, 2023

Rinvoq is a major pillar in AbbVie’s plan to stem revenue drops once biosimilars to its behemoth Humira (adalimumab) enter the market on a sustained basis this year. The FDA has recommended that patients start with 45mg Rinvoq once daily for 12 weeks, with a maintenance dosage of 15mg following the 12-week period.

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Mayo Clinic Dosage Biosimilars Immunization 105

Big Molecule Watch

JANUARY 26, 2024

ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). YUFLYMA® is also currently sold as a 40 mg dose, following FDA approval for that dosage strength in May 2023 and U.S. On January 17, 2024, Celltrion announced the U.S. launch of a new, 80 mg/0.8 ml dose and a 20 mg/0.2 ml dose on October 4, 2023.

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FDA Law Blog: Biosimilars

MAY 19, 2025

Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents (MMEs). 81, 89, 251.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Labelling Biosimilars Drug Pricing Dosage 104

Pharmaceutical Technology

JULY 25, 2022

This also includes biologics and biosimilars, which go through a different regulatory journey. There has been major growth in interest in biosimilars in recent times, says Watanabe. Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez.

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Biosimilars Medical Schools Dosage 119

FDA Law Blog: Biosimilars

JUNE 13, 2024

While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., FDA borrowed this definition from 21 C.F.R.

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Pharma Mirror

MARCH 31, 2022

The leading European pharmaceutical marketplace now hosts more than 85 000 CTD dossiers for finished dosage formulation products. As a response to increasing demand, Pipelinepharma will introduce biosimilar drugs into a separate category.

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Pharmaceutical Business Review

AUGUST 2, 2024

biosimilar products to reference medicine Stelara. The findings up to Week 52 showed comparable efficacy between the biosimilar and the reference product, Stelara, in patients with moderate-to-severe plaque psoriasis. The subcutaneous form is available in two dosages: 45mg/0.5ml or 90mg/1ml solution in a single-use, prefilled syringe.

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Drug Patent Watch

JANUARY 7, 2025

They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. “2021 Generic Drug & Biosimilars Access & Savings in the U.S. Food and Drug Administration. “Generic Drugs: Questions & Answers.”

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Communication Dosage Drug Pricing Packaging 71

Big Molecule Watch

MARCH 1, 2024

As background: the IRA defines “qualifying single source drugs” as drugs that are, among other things, (a) approved or licensed under the NDA or BLA provisions of the FDCA or BPCIA and (b) not the reference product for any generic or biosimilar that is “approved and marketed” (or “licensed and marketed”) pursuant to an ANDA or aBLA.

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Biosimilars Drug Pricing Dosage Documentation 59

Pharma in Brief

SEPTEMBER 8, 2022

This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. JAMP filed a new drug submission ( NDS ) for its biosimilar adalimumab product, SIMLANDI, in three presentations: (i) a 40 mg/0.4 Guidance Document : Information and Submission Requirements for Biosimilar Biologic Drugs.

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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., NDA or BLA) drugs.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

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”). The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

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Controlled Substances Documentation Dosage Prescription Filling 139

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. The Court also found that two other patents, which cover dosage regimens and new uses of adalimumab, are invalid for obviousness.

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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.,

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Dosage Pharmaceutical Manufacturing Drug Pricing 59

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

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Communication Dosage Biosimilars 105

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. For example: Reduced stay. Revised section 8 damages.

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Biosimilars Dosage Documentation 52

Big Molecule Watch

JUNE 23, 2023

The challenged claims generally relate to pharmaceutical dosages of eculizumab and methods for treating paroxysmal nocturnal hemoglobinuria with eculizumab. Stay tuned to BMW for future developments on these IPRs, and check out our PTAB Tracker for information on pending and concluded IPRs on other biosimilar products. 10,703,809.

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Pharma in Brief

NOVEMBER 5, 2023

For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product. The government is seeking feedback on the proposed amendments. Requirements for obtaining a listing are set out in O.

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FDA Law Blog: Biosimilars

JULY 31, 2023

In addition, for each partial filling whether requested by the prescriber on the prescription or during consultation with the pharmacist, the pharmacy must maintain a dispensing record of each dispensing date, name or initials of the individual dispensing, controlled substance name and dosage form, date filled, and quantity dispensed.

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

Pharmaceutical Technology

MAY 26, 2023

This newest indication continues AbbVie’s strategic push within the immunology marketplace to replace the diminishing revenues from its anti-TNF, Humira (adalimumab), following the asset’s loss of exclusivity and subsequent arrival of the adalimumab biosimilar, Amgen’s Amjevita in the US.

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Dosage Biosimilars 52

Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

1999P-2778) “request[ing] FDA disclose to the public through its Web site (1) the name of the innovator drug and approved dosage strengths, (2) the date the first Paragraph IV-containing ANDA is submitted, and (3) the dosage strengths included in that ANDA.” On October 4, 2000, a second Citizen Petition (FDA Legacy Docket No.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

Immediate-Release and High Dosage Opioids The government’s expert asserted that opiate prescriptions alone can create a “therapeutic duplication” red flag when two separate immediate release opioids are prescribed in their highest strength version. As for high dosage opioid prescriptions, the expert found that: Patient A.R.

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Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

MARCH 26, 2024

Because a “drug product” is defined by regulation as a “Finished dosage form. that contains a drug substance ,” FTC explains that “only those [patents] that claim the finished dosage form containing the drug substance of the relevant NDA” can be listed. Teva’s patents do not meet that criterion.

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Pharma in Brief

JUNE 21, 2020

those sold before January 1, 2021, into three categories: Grandfathered (DIN before August 21, 2019), Line Extension (DIN on or after August 21, 2021 for new dosage form/strength of Grandfathered medicine), and Gap (DIN on or after August 21, 2019 and first sale before January 1, 2021).

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FDA Law Blog: Biosimilars

MARCH 12, 2024

Each made similar points as the 3 that did delist: patents that claim the finished dosage form must be listed in the Orange Book, and the referenced patents claim the finished dosage form.

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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.

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