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?

Biosimilars 76

Biosimilars Drug Development Generic Medicine Diabetes 76

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.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

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.

Biosimilars 130

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.”

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Biosimilars Packaging Labelling Drug Development 130

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

STAT

SEPTEMBER 26, 2023

Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

Drug Pricing 324

Drug Pricing Biosimilars Drug Development 324

STAT

OCTOBER 9, 2023

Oh, it was also the day the company launched another Humira biosimilar.     There was obesity and liver disease, and computational biology and oncology. Then respiratory and inflammatory diseases. And don’t forget mental illness and retinal health.

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Biosimilars Drug Development 220

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.

Biosimilars 52

Biosimilars Vaccines Drug Development Diabetes 52

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 98

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 98

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.

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Biosimilars Drug Pricing Drug Development 130

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

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.

Biosimilars 100

Biosimilars Communication Drug Development 100

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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Biosimilars Drug Pricing Compounding Drug Development 130

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.

Biosimilars 84

Biosimilars Compounding Vaccines Drug Development 84

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

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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Biosimilars Drug Pricing Compounding Drug Development 100

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

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 83

Packaging Biosimilars Drug Development 83

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

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 78

Process Improvement Biosimilars Drug Development 78

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.

Biosimilars 79

Biosimilars Drug Development 79

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.

Biosimilars 78

Biosimilars Communication Drug Development 78

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 Immunity Immunization 68

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.

Biosimilars 59

Biosimilars Drug Development 59

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 79

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Drug Development 79

FDA Law Blog: Biosimilars

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.

Drug Development 59

Drug Development 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 82

Drug Development Biosimilars Compounding 82

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.

Drug Development 98

Drug Development Immunity Immunization 98

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 40

Generic Medicine Biosimilars Immunity Immunization 40

Pharmaceutical Technology

SEPTEMBER 13, 2022

Together, these strategies are anticipated to boost development processes from pre-clinical to first-in-human clinical trials with quicker transition times. We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless and rapid fashion.”.

Biosimilars 52

Biosimilars Compounding Drug Development 52

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 40

Generic Medicine Immunity Immunization Biosimilars 40

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 40

Generic Medicine Immunity Immunization Biosimilars 40

FDA Law Blog: Biosimilars

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

As a Principal Drug Regulatory Expert, Dr. Beitz joins HP&M’s Drug Development Team, which is comprised of attorneys and regulatory experts who assist companies on a range of drug and biological product legal, regulatory, and policy issues.

Drug Development 49

Drug Development Hospitals 49

FDA Law Blog: Biosimilars

AUGUST 23, 2023

FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website. Earlier this year, FDA published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (DHT Framework).

Drug Development 52

Drug Development Documentation 52

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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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 73