LifeProNow

APRIL 6, 2023

April 3, 2023 : “Sandoz, a global leader in off-patent (generic and biosimilar) medicines announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz ® (adalimumab).

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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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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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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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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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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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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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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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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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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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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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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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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.

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Biosimilars Packaging Immunization Immunity 52

European Pharmaceutical Review

DECEMBER 13, 2022

Patient-centred pharmaceutical packaging: are we there yet? Interchangeability of biosimilars in the EU – the industry impact. Simplify, standardise, digitalise to transform manufacturing. Arnaud Robert and Brendan O’Callaghan, Sanofi. Giana Carli Lorenzini, Technical University of Denmark. REGULATORY INSIGHT. DRUG DEVELOPMENT.

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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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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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PharmaShots

APRIL 5, 2023

neovascular (wet) AMD Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care Byooviz was approved in Canada for the treatment of multiple eye disorders.

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Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.

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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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PharmaShots

MAY 24, 2023

Shots: The US FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira for the treatment of 8 conditions: RA, JIA, PsA, AS, CD, UC, PsO, and HS. of treatment Yuflyma is supplied as 40mg/0.4mL in single-dose prefilled autoinjectors (Yuflyma AI) and single-dose prefilled syringes.

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PharmaShots

FEBRUARY 1, 2023

Ximluci is expected to be available in the UK in 2023 The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults.

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Biosimilars Packaging Diabetes Hospitals 40

PharmaShots

MARCH 1, 2023

In preclinical studies, HLX15 is highly similar to daratumumab Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US Date- February 01, 2023 Product: Amjevita The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases.

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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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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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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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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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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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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.

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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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Pharma in Brief

AUGUST 9, 2021

Generic drugs and biosimilars are not eligible for this application pathway. Finally, the amendments would also allow manufacturers of certain biologic drugs stockpiled for use in sporadic and infrequent emergency situations to indicate the drug’s expiry date by other means, rather than through a statement on the drug’s packaging.

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Labelling Packaging Biosimilars 98

FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M.

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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

Pharmaceutical Technology

MAY 23, 2023

While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. Generic and biosimilar firms are likely to heavily utilise this provision, and earlier market entry may lead to faster price drops for branded drugs.

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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