Express Pharma

DECEMBER 24, 2024

He was elevated to the present post after serving two years as Vice Chairman of Pharmexcil. Joshi has a career experience of around 30 years in different facets of pharmaceuticals, diagnostics, biologics and biosimilars, retail pharmacies and, healthcare media advocacy.

Biosimilars 105

Biosimilars 105

Express Pharma

SEPTEMBER 25, 2024

Biocon Biologics , a subsidiary of Biocon announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. This in the context of multiple switches between the reference product and the biosimilar as required of an interchangeability study.”

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Biosimilars 105

European Pharmaceutical Review

SEPTEMBER 11, 2023

has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). About the biosimilar development deal This agreement will help to expand access to biosimilar medicines , according to Samsung Bioepis. Samsung Bioepis Co.,

Biosimilars 96

Biosimilars 96

Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

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Biosimilars 97

European Pharmaceutical Review

AUGUST 4, 2023

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of This has developed following numerous adalimumab biosimilar offerings being brought to market. Worldwide sales for Humira peaked at $21.2

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Biosimilars 97

European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

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Biosimilars Dosage Labelling 98

Safe Biologics

JANUARY 10, 2023

In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. View all available modules of the ASBM/OSU Biosimilars Course here. In this module Dr. Feldman explains unique features of the U.S.

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Biosimilars Drug Pricing 100

European Pharmaceutical Review

FEBRUARY 2, 2023

AMJEVITA (adalimumab-atto), a biosimilar to Humira ® (adalimumab), is now available in the US. Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. Amgen currently has 11 biosimilar medicines in market or under development.

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Biosimilars 98

Express Pharma

MARCH 16, 2025

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. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

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Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

Safe Biologics

MARCH 21, 2024

On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. and Advisory Board Chair Philip Schneider, MS, FASHP.

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Biosimilars Labelling 100

Express Pharma

MARCH 2, 2025

market also continues to present a significant growth opportunity, driving many companies to evolve their leadership roles to stay competitive and compliant with stringent regulations. As the sector adapts to technological advancements, regulatory requirements, and increasing competition, several leadership role trends are emerging.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Drug Development 99

Express Pharma

DECEMBER 20, 2024

This transition has significant implications for the life sciences real estate market in India, presenting a dynamic blend of opportunities and challenges for 2025 and beyond. This tech-driven evolution has been mirrored in the demand for state-of-the-art research and development (R&D) facilities and production hubs.

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Biosimilars Vaccines 103

STAT

APRIL 4, 2024

Meanwhile, we are proud to present our latest list of interesting items for you to peruse. A drugmaker in China has developed a biosimilar version of Novo Nordisk’s popular diabetes drug Ozempic and applied for approval to sell it there, in a potential challenge to Novo expansion plans in the country , Reuters writes.

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Diabetes Biosimilars 278

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

I will be presenting Recent Hospital Employee Diversion: Mistakes Made, Lessons Learned, focusing on this timely topic, at the World Conference Forums 2025 Opioid & Fentanyl Abuse Management Congress in San Diego on February 20th. Employee diversion can also result in unwanted local and national publicity.

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Controlled Substances Hospitals 59

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

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. A biosimilar standard unique to the U.S.,

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Biosimilars Drug Pricing Drug Development 130

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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Biosimilars Packaging 130

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. Natalizumab is developed by Sandoz’s collaboration partner Polpharma Biologics.

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Biosimilars Packaging 64

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

Big Molecule Watch

JUNE 30, 2023

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States. In addition to CYLTEZO, the FDA has approved eight additional adalimumab biosimilars over the last six years.

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Biosimilars 64

Drug Patent Watch

MARCH 31, 2025

The market presents numerous opportunities for growth, including expanding into emerging markets and developing more complex generic medications. Regulatory hurdles, intellectual property disputes, and quality control issues are key challenges facing the market.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

SEPTEMBER 26, 2023

The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential.” The site is planned to be completed by 2026.

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Biosimilars Dosage Packaging 59

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). REGISTER for the webinar 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). REGISTER for the webinar here.

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Biosimilars Drug Pricing 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). Read the whitepaper here.

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Biosimilars Drug Pricing Compounding Drug Development 130

Putting Patients First Blog

MAY 26, 2023

Biosimilars briefing Event Time: 2:00 - 3:00 p.m. ET Event Location: Virtual The National Health Council invites you to join us for a webinar on the latest developments with biosimilars on Monday, June 12 at 2 p.m. This briefing will focus on the value biosimilars hold for patient communities and our health care system.

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Biosimilars Communication 52

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

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Biosimilars Documentation Drug Pricing 130

Express Pharma

JULY 3, 2023

There is no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology.

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Biosimilars Drug Development Generic Medicine Diabetes 95

Safe Biologics

DECEMBER 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland. ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”.

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Biosimilars Communication Drug Development 100

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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Drug Pricing Biosimilars Drug Development 130

Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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Biosimilars Communication Labelling Documentation 49

Safe Biologics

JUNE 6, 2024

Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies. View the resource guide here.

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Biosimilars Labelling 100

Big Molecule Watch

FEBRUARY 1, 2024

Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. FDA Accepts Accord BioPharma’s BLA for Ustekinumab Biosimilar On January 4, 2024, Accord BioPharma, Inc.

Biosimilars 49

Biosimilars 49

Safe Biologics

MAY 21, 2024

Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a r esponse published in GaBI Journal. Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such.

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Biosimilars Documentation 100

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

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Biosimilars Labelling Diabetes 56

Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. Feldman explains unique features of the U.S. Reilly, Esq.

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Biosimilars Drug Pricing 100

European Pharmaceutical Review

JANUARY 31, 2025

Over 100 biosimilar medicines are approved for nearly 30 reference medicines, testimony to the rigour of the scientific standards leading to the European authorisation process. This makes biosimilar medicines highly relevant. A significant number of the possible biosimilar candidates are not blockbuster medicines.

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Biosimilars 52