Safe Biologics

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.

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Biosimilars Drug Pricing Packaging Labelling 130

Pharmaceutical Technology

JULY 26, 2022

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions.

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Pharmaceutical Business Review

FEBRUARY 25, 2025

Yesintek is claimed to be one of the first Stelara (ustekinumab) biosimilar market entrants in the US. Biocon Biologics CEO and managing directorShreehas Tambe said:The launch of Yesintek marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars.

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Biosimilars Packaging Immunization Immunity 52

Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

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Biosimilars Packaging Labelling Drug Development 130

Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.

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Biosimilars Labelling Drug Pricing Packaging 130

Pharmaceutical Technology

JANUARY 31, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Sandoz’s citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab) biosimilar.

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Biosimilars Packaging 64

European Pharmaceutical Review

JANUARY 10, 2023

In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. Bio packaging zone . Pharmapack’s bio packaging zone builds on its long history of being at the forefront of innovations in biological drug delivery.

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Packaging Biosimilars 96

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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Biosimilars Dosage Packaging 59

PharmaTech

MAY 31, 2023

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

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Biosimilars Packaging 52

Safe Biologics

SEPTEMBER 27, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. European biosimilar uptake varies by country and product but hovers within the 20-80% range. However, S.6

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Biosimilars Packaging 100

European Pharmaceutical Review

FEBRUARY 2, 2023

The winners of Pharmapack Europe’s 2023 awards have been announced, presented across a range of innovative recyclable packaging, drug delivery solutions, and reusable connected devices. The winner in the Eco-Design category was a high grade, 100 percent PET blister packaging.

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Packaging Medication Delivery Biosimilars 98

Pharmaceutical Business Review

OCTOBER 1, 2024

Fresenius Kabi and Formycon signed an international commercialisation deal in February last year for the ustekinumab biosimilar candidate for various markets across the globe. Otulfi is said to be the fourth biosimilar of is Fresenius Kabi to receive marketing authorisation in the US.

Biosimilars 52

Biosimilars Packaging Immunization Immunity 52

Pharmaceutical Technology

MAY 26, 2023

The European Medicines Agency (EMA) has accepted two marketing authorisation applications (MAA) from Sandoz for the proposed biosimilar denosumab. The submission was supported by a comprehensive analytical and clinical data package, including data from a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trial.

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Biosimilars Packaging 52

Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The BLA submission is supported by a comprehensive analytical and clinical data package, including the Phase I/III ROSALIA trial data.

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Biosimilars Packaging 52

Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients.

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Packaging Biosimilars Labelling Vaccines 105

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues.

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Packaging Documentation Compounding 59

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Biosimilars Packaging 59

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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Biosimilars Packaging 52

PharmaTech

FEBRUARY 13, 2023

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

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Biosimilars Packaging 40

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Biosimilars Packaging Vaccines 64

Express Pharma

JUNE 5, 2023

It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. Also, the packaging in which drugs and other medication are delivered to end-consumers is undergoing certain changes.

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Packaging Vaccines Biosimilars 104

Drug Patent Watch

JANUARY 7, 2025

When educating elderly patients: Be patient and take extra time to explain concepts Use larger print materials for easier reading Address concerns about changes in pill appearance or packaging Communicating with Young Adults Younger patients may be more open to generic drugs but might lack knowledge about how they work. ” FDA.gov, 2021.

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Communication Dosage Drug Pricing Packaging 89

RX Note

DECEMBER 11, 2023

Some medications are supplied in amber (light-protected) vials, while others are stored in the original packaging (foil overwrap or box) until needed. Many medications should be protected from light during storage to avoid degradation.

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Packaging Biosimilars 40

Pharma in Brief

DECEMBER 3, 2020

Sponsors will be required to file an NDS with a complete data package for products previously authorized through the foreign decision pathway, or a supplemental NDS for drugs previously authorized under the expanded indication pathway. . require market authorization holders to meet post-marketing regulatory requirements; and.

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Vaccines Labelling Biosimilars Packaging 98

FDA Law Blog: Biosimilars

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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Packaging 52

Big Molecule Watch

JANUARY 5, 2024

District Court for the Northern District of West Virginia, alleging infringement of 51 patents under the BPCIA based on Samsung’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA (aflibercept). Three utility patents and five design patents alleged to be infringed by SB15 packaging and syringe cap: U.S. Patent Nos.

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Packaging Biosimilars Documentation 49

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Under the agreement, Celltrion will exclusively supply to Rani the ustekinumab biosimilar drug substance (CT-P43) required for its RT-111 programme. the enteric coating and the capsule dissolve.

Biosimilars 105

Biosimilars Diabetes Immunization Immunity 105

Big Molecule Watch

JANUARY 22, 2024

Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s submission of an aBLA for ABP 938, a proposed biosimilar of EYLEA (aflibercept). One patent related to packaging: S. Regeneron”) filed a Complaint in the U.S.

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Biosimilars Packaging 49

FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M.

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Packaging Labelling 59

pharmaphorum

JULY 22, 2021

We leveraged our ample experience in conducting global clinical trials in the field of monoclonal antibody biosimilar and designed the clinical trial for CT-P59 according to its mechanism of action of a monoclonal antibody to treat COVID-19 patients in early stages.”.

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Communication Packaging Biosimilars Pharmaceutical Companies 105

pharmaphorum

JANUARY 27, 2023

The same goes for many commodities used in the production process for key medicines, from solvents through to packaging. About the author Richard Saynor was appointed CEO of Sandoz in 2019, a Novartis generics and biosimilars division. However, as with hope, they can never replace a sound strategy.

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Packaging Biosimilars Vaccines 105

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Once the device is required to bear a UDI, any NHRIC and NDC codes will no longer be permitted on the device label or device packaging.

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Labelling Packaging Documentation 45

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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Packaging Drug Development Documentation 64

FDA Law Blog: Biosimilars

JULY 10, 2023

The AI response package must respond completely to all parts of the deficiencies and include all information needed to address the deficiencies; in other words, a firm cannot submit a partially completed response package and plan to submit another AI response package at a later date to address remaining deficiencies.

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Documentation Packaging Communication Labelling 75

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Labelling Packaging Documentation 59

Express Pharma

DECEMBER 7, 2023

Bhanu said that now India needs to be able to anticipate future needs and work with all stake holders to create and implement strategies which will foster innovation and promote research in high value products such as antibiotics, biosimilars, oncology medicines etc.

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Packaging Biosimilars 104

pharmaphorum

FEBRUARY 3, 2022

Delve into the world of biologics and biosimilars and what these mean for the injectable drug market. Develop your understanding of high-volume and long-acting injectable compounds. Explore the sustainable possibilities that can be adapted within the industry for a green future. Device Engineering. Human Factors. Injectables.

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Compounding Packaging Biosimilars Vaccines 52