Pharmacy Times

JUNE 15, 2023

Despite having a lower cost of development than the innovator, romiplostim biosimilar has comparable efficacy and safety in patients with chronic immune thrombocytopenia.

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Pharmaceutical Business Review

FEBRUARY 25, 2025

Yesintek is claimed to be one of the first Stelara (ustekinumab) biosimilar market entrants in the US. Biocon Biologics CEO and managing directorShreehas Tambe said:The launch of Yesintek marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars.

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Big Molecule Watch

JULY 5, 2023

In the last week, six adalimumab biosimilars referencing HUMIRA entered the market. These biosimilar products are each offered in autoinjector and prefilled syringe options. The launches are the first for adalimumab biosimilars since Amgen’s AMJEVITA launched in January 2023.

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Express Pharma

JULY 3, 2023

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. The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025.

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Biosimilars Drug Development Generic Medicine Diabetes 95

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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Pharmaceutical Business Review

OCTOBER 1, 2024

Fresenius Kabi and Formycon signed an international commercialisation deal in February last year for the ustekinumab biosimilar candidate for various markets across the globe. A human monoclonal antibody, Ustekinumab acts on the interleukin-12 and interleukin-23 cytokines which hold a key role in inflammatory and immune responses.

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Biosimilars Packaging Immunity Immunization 52

Big Molecule Watch

MARCH 15, 2024

On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

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Express Pharma

JUNE 29, 2023

An alternative to the more expensive Avastin biologic, Bevacizumab is the 6 th biosimilar from Enzene Biosciences’ strong biosimilar pipeline that has been launched in the Indian market. Sandeep Singh, MD of Alkem Laboratories said, “Enzene Biosciences is poised to revolutionize the landscape of biosimilar manufacturing.

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Quality Matters

JUNE 17, 2024

Biologics and biosimilars – the basics Biologic medicines – “biologics” for short. And what about “biosimilars” ? Read on to learn some of the basics about biologics, biosimilars and why patients taking them can be confident in their quality. What are biosimilars? You’ve probably seen commercials for some of them on TV.

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BioPharma Dive

APRIL 5, 2024

The German pharmaceutical company is “streamlining” its custom-facing teams behind Cyltezo, a copycat version of AbbVie’s immune disease drug Humira.

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Pharmacy Times

APRIL 17, 2024

Ustekinumab (Stelara; Janssen Immunology) is a human monoclonal antibody that treats immune-mediated diseases such as psoriasis and psoriatic arthritis.

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pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

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Pharmafile

OCTOBER 30, 2023

The drug is the first biosimilar to Opdivo to be part of a phase 3 clinical study in China. The drug is a monoclonal antibody intended to enhance the immune response of […] The post First patient enrolled in Boan Biotech’s phase 3 trial for Nivolumab in China appeared first on Pharmafile.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Importantly, because FDA has sovereign immunity from damages claims, sponsors trapped in S. That bill is S.

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Immunity Immunization Biosimilars Labelling 59

PharmaShots

JUNE 27, 2023

How was the ACR’22 experience for biosimilars for Biogen? We saw Biogen presented multiple results for different biosimilar molecules. Smriti: Can we talk about BIIB800, a tocilizumab biosimilar? Smriti: Can we talk about IMRALDI’s (adalimumab biosimilar) PROPER study and its design?

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition.

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pharmaphorum

NOVEMBER 17, 2020

Lead Pharma has signed a potential 260 million euro ($308 million) deal with Roche to develop small molecule drugs for immune diseases. The company has been working with Sanofi since 2015 on a small molecule targeting ROR gamma, a regulator of T-helper 17 immune cells. Roche last year signed a $792.5

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Big Molecule Watch

JANUARY 6, 2025

On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsens STELARA. STEQEYMA is the seventh ustekinumab biosimilar to be approved by the FDA. STEQEYMA is the seventh ustekinumab biosimilar to be approved by the FDA.

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Pharmaceutical Technology

FEBRUARY 28, 2023

It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz.

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Generic Medicine Biosimilars Immunity Immunization 68

Quality Matters

FEBRUARY 6, 2025

To understand monoclonal antibody drugs, its necessary to first know a little about how antibodies work in the bodys immune system. The immune system protects the body from harmful substances, microbes and abnormal cells that can cause diseases. Anything that triggers an immune response is called an antigen.

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pharmaphorum

SEPTEMBER 12, 2020

None of the immune-modulating drugs approved to treat ulcerative colitis – even biosimilars – are priced low enough to be cost-effective, says the Institute for Clinical and Economic Review (ICER).

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Pharmacy Times

JANUARY 5, 2024

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

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pharmaphorum

APRIL 30, 2021

It’s Merck’s last remaining COVID-19 programme after it scrapped development of its vaccine candidate and immune modulator MK-7110. The guidance doesn’t include any potential revenues from COVID-19 drug candidate molnupiravir, which could be the first oral antiviral for the disease. Overall revenues for the quarter came in at $12.1

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European Pharmaceutical Review

FEBRUARY 22, 2023

In 2023, Rani Therapeutics plans to begin three additional Phase I studies with pipeline molecules RT-105 (containing an adalimumab biosimilar), RT-110 (containing PTH for hypo-parathyroidism) and RT-111 (containing an ustekinumab biosimilar for psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis).

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Biosimilars Diabetes Immunity Immunization 105

pharmaphorum

NOVEMBER 4, 2020

Tecentriq is becoming increasingly important to Roche as sales of its “big three” cancer drugs Avastin, Herceptin, and Rituxan/MabThera fall away because of competition from cheaper biosimilars. Sales of Tecentriq were up 64% in the first nine months of this year to just over 2 billion swiss francs ($2.2

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Pharmaceutical Technology

JUNE 19, 2023

Coherus BioSciences chairman and CEO Denny Lanfear stated: “This transaction is well-timed, as it coincides with the accelerating growth of our biosimilar revenues driven by the launch of CIMERLI and near-term launch of YUSIMRY. The transaction is anticipated to be concluded in the third quarter of 2023.

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Express Pharma

OCTOBER 9, 2024

He put forth the importance of Research and Development and regulatory systems, particularly for the deeper work needed in the biologics and biosimilar space. Dr Chawla noted the growth of the sector and the focus areas that offer massive opportunities for Industry.

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Pharmaceutical Technology

FEBRUARY 28, 2023

It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz.

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Generic Medicine Immunity Immunization Biosimilars 40

Pharmaceutical Technology

FEBRUARY 28, 2023

It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz.

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Generic Medicine Immunity Immunization Biosimilars 40

pharmaphorum

JUNE 20, 2022

“With more than 30 ongoing or planned trials in inflammatory bowel disease, AbbVie is committed to advancing the standards of care for patients by exploring and investing in research for those living with immune-mediated, gastroenterological conditions,” said Hudson.

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Pharmaceutical Technology

JUNE 6, 2023

PF-06835375 is a biologic commercialized by Pfizer, with a leading Phase II program in Idiopathic Thrombocytopenic Purpura (Immune Thrombocytopenic Purpura). PF-06835375 Overview PF-06835375 is under development for the treatment of seropositive systemic lupus erythematosus, primary immune thrombocytopenia (ITP) and rheumatoid arthritis.

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pharmaphorum

DECEMBER 18, 2020

One of the talking points at the American Society of Clinical Oncology (ASCO) in 2019, Margenza is a tweaked version of Roche’s Herceptin (trastuzumab), which dominated the HER2-mutated breast cancer market for years until the recent launch of cut-price biosimilar competitors.

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FDA Law Blog: Biosimilars

MARCH 13, 2023

At an EL-PFDD meeting for people living with Wiskott-Aldrich syndrome , we heard: (After receiving gene therapy) But gradually, we saw our son’s immune system start to work again. Instead, he is getting stronger, has started to stand up on his own, and is now walking with the assistance of orthotics, and a walker.

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Pharmaceutical Technology

FEBRUARY 28, 2023

It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz.

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Generic Medicine Biosimilars Immunity Immunization 40

PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

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PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Though the exact working of Actemra in the body is not known, from early research, it is suggested that Actemra blocks the connecting of IL-6 protein to the cells and prevents overactivity of the immune system.

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Big Molecule Watch

AUGUST 21, 2023

Food and Drug administration in May 2023 for use in adults over age 60, becoming the world’s first approved RSV immunizations for adults. According to the complaint, AVREXY and ABRYSVO were approved by the U.S. GSK describes the four asserted patents, U.S. Patent Nos.

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Vaccines Immunization Immunity Biosimilars 52