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.

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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.”

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Express Pharma

JULY 3, 2023

How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?

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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.

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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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European Pharmaceutical Review

SEPTEMBER 25, 2024

This report delves into the latest developments impacting the pharmaceutical biologic drug sector today. Inside, articles explore current key topics including biosimilars, antibody drugs, manufacturing, drug delivery and vaccines.

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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

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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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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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.

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Pharmaceutical Commerce

MARCH 10, 2025

The latest news for pharma industry insiders.

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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.

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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.

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Safe Biologics

OCTOBER 10, 2023

Department of Health and Human Services​ Clip 2: Drug Developer Discusses Impacts on R&D – Steven Potts, PhD, MBA – View clip Clip 3: Innovation and Patient Access – Andrew Spiegel, Esq. director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Pharmaceutical Technology

OCTOBER 28, 2022

Practising QbD in biosimilar product development. One area in which QbD should be practised is that of biosimilars, also known as follow-on biologics or subsequent entry biologics. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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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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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.

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European Pharmaceutical Review

NOVEMBER 6, 2023

Demand for cell lines “in drug development , vaccine production, and therapeutic research is surging”, setting the market up for significant expansion, Ghosh noted. Mammalian cell line development Mammalian cell line development is anticipated to see “significant growth” in overall the cell line development market.

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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).

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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.

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Labelling Biosimilars Drug Pricing Dosage 104

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.

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Express Pharma

JANUARY 3, 2025

Investing in cutting-edge research, particularly in biosimilars, novel biologics, and cell and gene therapies, will be crucial. Integrating advanced technologies such as AI and automation can further enhance operational efficiency, accelerate drug development timelines, and drive cost-effectiveness.

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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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Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. By 2022, that time was nearly cut in half, at nine to 12 months, and even shorter development timelines are expected in the next few years.

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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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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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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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.

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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.

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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.

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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.

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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.

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FDA Law Blog: Biosimilars

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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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.

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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.

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Diabetes Biosimilars Drug Development 95

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Biopharmaceutical Research & Development: The Process Behind New Medicines. 2022;12(7):3049-3062.

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