PharmaVoice

JUNE 23, 2025

Voices Q&A Profiles Biotech Spotlight First 90 Days Opinions Topics Biotech Commercialization Leadership Manufacturing Patient Pharma Policy & Regulation Research & Development Library Events Press Releases PharmaVoice 100 Nominate 2024 PV100 2023 PV100 Sign up Search Sign up Search An article from Megablockbusters are the holy grail.

Diabetes 147

Diabetes Packaging Biosimilars 147

Express Pharma

MARCH 16, 2025

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

Biosimilars 110

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

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).

Biosimilars 130

Biosimilars Packaging 130

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.

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

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.

Packaging 96

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.

Biosimilars 59

Biosimilars Dosage Packaging 59

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.

Biosimilars 40

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.

Biosimilars 40

Biosimilars Packaging Labelling 40

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.

Biosimilars 40

Biosimilars Packaging 40

FDA Law Blog: Biosimilars

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”).

Biosimilars 59

Biosimilars Packaging 59

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. So, what is special about September 24, 2023? Devices can have both a UPC code and a UDI on their label and package.

Labelling 45

Labelling Packaging Documentation 45

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.

Biosimilars 52

Biosimilars Packaging 52

Express Pharma

DECEMBER 7, 2023

” After the resounding success of Ahmedabad Pharma Summit 2023, Express Pharma recently hosted the fourth edition of Vizag Pharma Summit on May 19, 2023 at the Hotel Taj Gateway in Vishakhapatnam. Bhanu was also emphatic on the importance of meaningful partnerships and collaborations to grow and thrive in an era of disruptions.

Packaging 104

Packaging Biosimilars 104

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. This trial is anticipated to begin in the second half of 2023.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

FDA Law Blog: Biosimilars

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. By Karla L. the ability to associate the saleable return product with the transaction information/statement with the particular product). Guidance at 4.

Packaging 52

Packaging 52

Pharmaceutical Technology

JUNE 25, 2025

Go deeper with GlobalData Reports Biosimilars in Pharmaceuticals: Peptide-based compositions for Alzh. Over the past few decades, Alzheimer’s research and development (R&D) has seen a low success rate due to failure to demonstrate efficacy in clinical trials. Give your business an edge with our leading industry insights.

Packaging 59

Packaging Biosimilars Communication Hospitals 59

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.

Packaging 49

Packaging Documentation Biosimilars 49

Putting Patients First Blog

JULY 18, 2023

Washington Representatives Summer Meeting Overview July 18, 2023 By: Allen Pinn, Coordinator, Policy After much anticipation, the NHC held its inaugural Washington Representatives Summer meeting at Top of the Hill (TOTH) in Washington, DC. All the panelists were optimistic that the previous listed topics have widespread bipartisan support.

Packaging 52

Packaging Biosimilars 52

PharmaShots

FEBRUARY 27, 2023

Some of their thoughts are: Mr. Mekala Rao (Chairman – Technology Global PHT Expo & Summit – 2023 and President – Atachi Systems, USA) – “motivation to attend Global PHT is to understand the cultural gap in the production of innovative medicine, healthcare systems between eastern and western world.

Biosimilars 40

Biosimilars Diabetes Packaging Hospitals 40

Big Molecule Watch

JANUARY 22, 2024

Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. On October 31, 2023, Amgen announced that the FDA accepted its aBLA for ABP 938. One patent related to packaging: S. Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. Patent Nos.

Biosimilars 49

Biosimilars Packaging 49

Express Pharma

MAY 8, 2025

Lupin Manufacturing Solutions (LMS) was officially incorporated in November 2023. And, since most of the future growth will come from biologics and biosimilars, how will India make its mark as a global biosimilar CDMO market? Tell us more about Lupin Manufacturing Solutions.

Biosimilars 59

Biosimilars Packaging 59

FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

Packaging 59

Packaging Communication 59

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

Labelling 59

Labelling Packaging Documentation 59

Pharmaceutical Technology

JULY 1, 2025

Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. Reports Biosimilars in Immunology Data Insights The gold standard of business intelligence.

Packaging 52

Packaging Drug Development Chemotherapy Biosimilars 52

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. 355(j)(2)(A)(v). .

Labelling 40

Labelling Packaging 40

pharmaphorum

JUNE 27, 2025

Head to our online registration page to take advantage of our most competitive rates and group packages: [link] Image 27 June, 2025 Bookmark this Oncology Merck at ASCO 2025: Cancer is a constellation of many rare d. Market Access Sponsored Bridging research and clinical guidelines – interactive stra.

Drug Development 52

Drug Development Diabetes Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

JUNE 12, 2023

Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”

Labelling 45

Labelling Packaging 45

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

Packaging 59

Packaging Documentation Labelling Communication 59

Safe Biologics

AUGUST 23, 2024

as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,

Biosimilars 130

Biosimilars Chemotherapy Packaging 130

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data Additionally, the company initiates PK study for AVT05 in Jan 2023. 84% vs 64%) & 2yr. (60%

Biosimilars 40

Biosimilars Packaging Pharmaceutical Companies Diabetes 40

pharmaphorum

JANUARY 27, 2023

It’s wise advice from the “Sage of Omaha”; indeed, one highly respected financial newspaper began its 2023 predictions by conceding that it had been wrong on five major counts for 2022. The same goes for many commodities used in the production process for key medicines, from solvents through to packaging.

Packaging 105

Packaging Biosimilars Vaccines 105

Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

Pharmacy Technician 51

Pharmacy Technician Diabetes Compounding Pharmacies Pharmacy Management 51

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

Pharmacy Times

JUNE 11, 2025

Package insert. FDA approves tablet formulation of BeOne's BRUKINSA for all approved indications. News Release. Released June 11, 2025. Accessed June 11, 2025. BeiGene USA, Inc.; Accessed June 11, 2025.

Pharmacy Technician 29

Pharmacy Technician Compounding Pharmacies Biosimilars Pharmacy Management 29

Pharmacy Times

JULY 3, 2025

It's cognitive behavioral therapy packaged as a digital experience. I've even seen VR experiences, so it can be packaged in any type of digital experience. Areo Nazari, PharmD: PDTs are digital or software-based treatments that are approved by the FDA to treat disease.

Pharmacy Technician 26

Pharmacy Technician Compounding Pharmacies Pharmacy Management Immunity 26

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.

Packaging 59

Packaging Labelling Vaccines 59

PharmaTech

JUNE 20, 2025

Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives. BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools.

Dosage 59

Dosage Drug Development Vaccines Packaging 59