European Pharmaceutical Review

JANUARY 2, 2024

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. It also lowers the regulatory burden too, the paper reported. [In concluded. “To

Drug Development 105

Drug Development Biosimilars Documentation 105

Express Pharma

MAY 10, 2023

The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion. Development of the biosimilars will ramp-up over the coming 12-18 months.”

Biosimilars 97

Biosimilars Drug Development 97

Express Pharma

MARCH 2, 2025

Large Pharma companies in India have already been appointing North America focused Regulatory Affairs leadership roles, responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.

Biosimilars 99

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 99

FDA Law Blog: Biosimilars

APRIL 8, 2025

Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).

Documentation 144

Documentation Labelling Drug Development 144

Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Express Pharma

MARCH 16, 2025

First, advanced research and development (R&D) and biologics will be critical. To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. and Europe.

Biosimilars 110

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

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

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.”

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). View the poster here.

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Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). View the poster here.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Pharmaceutical Technology

FEBRUARY 23, 2023

Ranibizumab biosimilar is under clinical development by Generium and currently in Phase III for Wet (Neovascular / Exudative) Macular Degeneration. GlobalData’s report assesses how Ranibizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Biosimilars 52

Biosimilars Diabetes Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

NOVEMBER 25, 2024

The pharmaceutical analytical testing market is seeing significant growth following a greater incidence in the complexity of medicine development and higher demand for biologics and biosimilars, according to a report by Straits Research Pvt. Their analysis projected that the market will exceed a value of $15.46 billion by 2032.

Drug Development 52

Drug Development Biosimilars Compounding Pharmaceutical Companies 52

Safe Biologics

DECEMBER 8, 2022

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

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Biosimilars Communication Drug Development 100

Drug Patent Watch

DECEMBER 12, 2024

Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

Pharmaceutical Companies 94

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Drug Development 94

European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

Biosimilars 105

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 105

Safe Biologics

JULY 13, 2023

On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines which focused on unintended consequences for patient access that may result from the implementation of the Inflation Reduction Act (IRA).

Drug Pricing 130

Drug Pricing Biosimilars Drug Development 130

Pharmaceutical Commerce

MARCH 10, 2025

The latest news for pharma industry insiders.

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Drug Development Biosimilars 59

FDA Law Blog: Biosimilars

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.

Drug Development 52

Drug Development 52

European Pharmaceutical Review

DECEMBER 13, 2022

Interchangeability of biosimilars in the EU – the industry impact. DRUG DEVELOPMENT. Patient-centred pharmaceutical packaging: are we there yet? Giana Carli Lorenzini, Technical University of Denmark. REGULATORY INSIGHT. Marie Manley and Chris Boyle, Sidley Austin LLP.

Packaging 98

Packaging Biosimilars Drug Development 98

FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial.

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Drug Development Labelling 69

FDA Law Blog: Biosimilars

APRIL 2, 2024

“FDA believes this change would effectuate timelier and more cost-efficient generic drug development.” Finally, FDA asks Congress to amend to FDCA § 505(j) to address the submission and review of drug-device combination product ANDAs, as well as drug products submitted in an ANDA that are used with devices.

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

FDA Law Blog: Biosimilars

APRIL 1, 2025

While much may be in flux, the central tenet of drug development remains the same, develop drugs that are safe and effective drugs for patients, through streamlined, efficient, and cost-effective development programs. Therein lies the opportunity.

Communication 77

Communication Drug Development 77

Pharmaceutical Technology

MARCH 2, 2023

Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in Phase III for Rheumatoid Arthritis. According to GlobalData, Phase III drugs for Rheumatoid Arthritis have a 65% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

Biosimilars 40

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 40

Express Pharma

MAY 24, 2023

The first day of the conference mainly consisted of portfolio management topics where industry leaders like Dr Mukesh Kumar, Edward Coutinho, Dr Paras Vasanani and Pradeep Patni covered issues related to biosimilars, pipeline management and collaborative partnering process to manage the planning perspectives and uncertainties efficiently.

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Biosimilars Communication Drug Development 96

European Pharmaceutical Review

NOVEMBER 9, 2023

In this issue, Peter Stenico, Biosimilar Global Platform Head at Sandoz, highlights how emerging technology platforms such as nanobodies, ADCs and cell and gene therapies are “on course to revolutionise medicine,” with significant growth anticipated over the next decade.

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Biosimilars Drug Development 98

European Pharmaceutical Review

FEBRUARY 20, 2024

Other key influences helping the upstream bioprocessing market expand include drug development, antibody manufacturing, as well as a higher need for cell therapy research.

Process Improvement 98

Process Improvement Biosimilars Drug Development 98

European Pharmaceutical Review

MAY 17, 2023

QMS are the integrated processes and procedures that ensure that pharmaceutical products are developed, manufactured and distributed in compliance with regulatory requirements and meet the desired quality standards. This was due to widespread use of advanced digital technologies to improve overall manufacturing process results.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Drug Development 98

Express Pharma

JULY 21, 2024

key expectations include; 1) Strong Focus on Innovations: research in the areas of cell and gene therapy, new molecular entities, biologics and biosimilars should be promoted. 2) R&D Engine: The industry seeks increased incentives for research and development, such as tax deductions.

Biosimilars 105

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 105

Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

Insurance Coverage and Processing 59

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

Express Pharma

JUNE 5, 2023

Jakafi’s landmark approval in 2011 galvanised intensive drug development efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent. Sam Warburton, Oncology Analyst at GlobalData, comments, “Despite MF being a rare disease, it is a blockbuster market with significant commercial potential.

Drug Development 97

Drug Development Biosimilars Compounding 97

Pharmaceutical Technology

FEBRUARY 28, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Generic Medicine 68

Generic Medicine Biosimilars Immunization Immunity 68

pharmaphorum

JUNE 24, 2021

Lucentis has been approved by the FDA since 2006 for wet AMD and is a big earner for both Roche and Novartis, who share rights to the product with Roche selling the drug in the US and Novartis selling it in Europe and other markets. billion in US sales, while Novartis’ sales of the drug topped $1.9 billion in 2020 revenues.

Diabetes 95

Diabetes Biosimilars Drug Development 95

FDA Law Blog: Biosimilars

JUNE 27, 2023

James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development. Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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Drug Development Pharmaceutical Manufacturing 81

FDA Law Blog: Biosimilars

JANUARY 16, 2025

Marks promotion to Counsel reflects the value that he brings to the firm and his clients based on expansive and diverse experiences in the drug development arena, commented HPM Director James Valentine.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development 59

European Pharmaceutical Review

MAY 2, 2024

Recent developments in the biologic therapies sector include the authorisation of Pyzchiva ® (biosimilar ustekinumab) by the European Commission, and promising 12-month data for Roche’s subcutaneous injection of OCREVUS ® (ocrelizumab) for relapsing or primary progressive multiple sclerosis.

Biosimilars 105

Biosimilars Drug Development 105

European Pharmaceutical Review

APRIL 3, 2024

This is due to these companies looking to meet to the varied needs of pharmaceutical developers, according to the authors. This is contributing to a more streamlined and efficient approach to drug development, according to the report.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Compounding 52

FDA Law Blog: Biosimilars

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. The hybrid format was necessary due to limitations in the number of attendees who could be accommodated in-person in the handful of newly revamped meeting rooms.

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Biosimilars Drug Development 59