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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European Pharmaceutical Review

JANUARY 30, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for a citrate-free high concentration formulation (HCF) 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

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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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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Biosimilars Labelling Drug Pricing Packaging 130

STAT

JUNE 15, 2023

This calls for celebration with a cup of stimulation, and we are opening a new package of salted caramel mocha for the occasion. Earlier this month, Coherus said it will launch a biosimilar version of the drug at an 85% discount to the $6,922 list price and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27.

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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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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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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

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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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 71

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 78

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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Packaging Biosimilars Drug Development 83

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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Biosimilars Packaging 40

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

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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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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Biosimilars Diabetes Documentation Packaging 131

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 62

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 62

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

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 88

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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Putting Patients First Blog

JULY 18, 2023

In his remarks, Reiser discussed the current dynamics on the Hill and the possibility of an end-of-year health care package. During this session, each panelist responded to audience questions on a range of topics including: biosimilars, out-of-pocket costs, PBMs, and Medicare Part D redesign.

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Packaging Biosimilars 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.

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Biosimilars Dosage Packaging 59

FDA Law Blog: Biosimilars

MARCH 8, 2023

For any major changes, additional time will be granted between the release of the implementation package and production deployment. Although FDA intends to follow this schedule, emergency fixes may be implemented outside of the schedule. Although FDA intends to follow this schedule, emergency fixes may be implemented outside of the schedule.

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Packaging Communication 59

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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Packaging Communication 64

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

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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Biosimilars Packaging Labelling Hospitals 49

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. Sandoz Reports Real World Study Results of GP2013 (biosimilar, rituximab) for the Treatment of Rheumatoid Arthritis Date- May 08, 2023 Product: GP2013 (biosimilar, rituximab) The study incl. 84% vs 64%) & 2yr. (60%

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Biosimilars Packaging Diabetes Pharmaceutical Companies 40

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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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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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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Packaging Labelling Vaccines 59

FDA Law Blog: Biosimilars

MARCH 3, 2024

Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year.

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Packaging 102

Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. Solvias is well equipped to provide stability testing for all stages of drug development. HQ ADDRESS: Römerpark 2. 4303 Kaiseraugst.

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Vaccines Biosimilars Compounding Packaging 52

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 94