Express Pharma

FEBRUARY 20, 2025

The International Generic and Biosimilar Medicines Association (IGBA) has released a report titled “Gaming the System An Overview of Originator Companies Evergreening Strategies Used to Hinder Access to Generic and Biosimilar Products.” Practices previously seen in the U.S.

Biosimilars 66

Biosimilars Immunity Immunization 66

BioPharma Dive

APRIL 17, 2024

The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.

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Big Molecule Watch

SEPTEMBER 3, 2024

Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions.

Biosimilars 69

Biosimilars Immunity Immunization 69

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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Biosimilars Immunity Immunization Pharmaceutical Companies 98

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.

Immunity 48

Immunity Immunization Biosimilars 48

Big Molecule Watch

NOVEMBER 7, 2023

On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union. Being the first health care company to offer a tocilizumab biosimilar in the EU showcases [Fresenius’s] ambition to be leading also in the biopharma segment.”

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Biosimilars Immunity Immunization 64

Big Molecule Watch

SEPTEMBER 25, 2023

Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA. TYENNE is the first tocilizumab biosimilar approved in the EU.

Biosimilars 59

Biosimilars Diabetes Immunity Immunization 59

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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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

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.

Biosimilars 52

Biosimilars Packaging Immunity Immunization 52

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.

Biosimilars 52

Biosimilars Packaging Immunity Immunization 52

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.

Biosimilars 95

Biosimilars Immunity Immunization 95

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.

Biosimilars 49

Biosimilars Immunity Immunization 49

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.

Biosimilars 65

Biosimilars Immunity Immunization Pharmaceutical Companies 65

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.

Biosimilars 57

Biosimilars Immunity Immunization 57

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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Biosimilars Chemotherapy Immunity Immunization 126

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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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.

Biosimilars 64

Biosimilars Immunity Immunization 64

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.

Immunity 59

Immunity Immunization Biosimilars Labelling 59

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.

Mayo Clinic 105

Mayo Clinic Dosage Biosimilars Immunity 105

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

Immunity 72

Immunity Immunization Biosimilars 72

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.

Biosimilars 45

Biosimilars Immunity Immunization 45

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.

Generic Medicine 68

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.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Immunity Immunization Biosimilars 52

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).

Biosimilars 52

Biosimilars Immunization Immunity 52

Pharmacy Times

JANUARY 5, 2024

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

Immunity 26

Immunity Immunization Biosimilars 26

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).

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

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.

Biosimilars 52

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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.

Generic Medicine 40

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.

Generic Medicine 40

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.

Biosimilars 64

Biosimilars Immunity Immunization 64

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.

Immunity 40

Immunity Immunization Biosimilars Hospitals 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.

Generic Medicine 40

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 (..)

Biosimilars 53

Biosimilars Immunity Immunization 53

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

Diabetes 64

Diabetes Immunity Immunization Biosimilars 64

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.

Vaccines 52

Vaccines Immunity Immunization Biosimilars 52

pharmaphorum

MARCH 21, 2022

Like PD-1, LAG-3 is a negative regulator of T cells, suppressing their activity against cancer cells, so when that brake is released the immune system can attack and kill tumours. months, versus 4.6 months for Opdivo alone.

Biosimilars 52

Biosimilars Immunity Immunization 52