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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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

FEBRUARY 29, 2024

Biocon Biologics has signed a settlement and license agreement with Janssen Biotech, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara, in the US. The agreement licenses the company to launch in the US, in February 2025, once approved by the US FDA.

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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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Biosimilars Immunity Immunization Pharmaceutical Companies 62

Pharmaceutical Technology

FEBRUARY 14, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Biosimilars in Pharmaceuticals: Neuro-degenerative receptor binding drug compositions. AC Immune and F.

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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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Biosimilars Immunity Immunization 57

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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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

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 79

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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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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Biosimilars Immunity Immunization 64

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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Immunity Immunization Biosimilars 26

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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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

FEBRUARY 24, 2021

Higher biosimilar savings. Spain, like many European countries, have seen biosimilars as a route to helping manage pressure on health care spending. Back in 2020 savings from biosimilars were forecasted to really get going in that year and through to 2022.

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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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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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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 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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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

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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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

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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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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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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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 Immunity Immunization Biosimilars 52

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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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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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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Chemotherapy Biosimilars Immunity Immunization 52

PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

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PharmaShots

MAY 19, 2023

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)

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Pharmaceutical Technology

FEBRUARY 27, 2023

The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

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Pharmaceutical Technology

FEBRUARY 27, 2023

The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

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Biosimilars Immunity Immunization Hospitals 40

Pharmaceutical Technology

FEBRUARY 27, 2023

The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services.

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Biosimilars Immunity Immunization Hospitals 40

Pharmaceutical Technology

FEBRUARY 18, 2023

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

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Diabetes Generic Medicine Biosimilars Immunity 40

FDA Law Blog: Biosimilars

APRIL 8, 2024

This strikes us as another signal that FDA sees the policies of cGMP as evergreen, and largely immune to even seismic technology shifts. The new sub-offices are organized to review drugs by type, not by approval route.

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