The Checkup by Singlecare

MARCH 13, 2024

Food & Drug Administration (FDA) approved Jubbonti and Wyost, the first interchangeable biosimilars to the injectable medications Prolia and Xgeva , respectively. According to a 10-year review of clinical studies , it is a highly effective anti-osteoporosis therapy for patients at high risk of fracture. What is a biosimilar?

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European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). A new European biosimilar approval “This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.

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Pharmacy Times

JULY 19, 2022

Indications for adalimumab include ankylosing spondylitis, Crohn disease, chronic plaque psoriasis, juvenile idiopathic arthritis, moderate to severe rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

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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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Pharmacy Times

OCTOBER 19, 2023

The FDA is the only authority that can designate a biosimilar as interchangeable with its reference product, which requires that the product has similar clinical results for the same indication.

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Drug Store News

SEPTEMBER 7, 2022

Lannett anticipates launching biosimilar insulin glargine in the first half of 2024.

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The Checkup by Singlecare

MARCH 8, 2024

Instead, it has biosimilar versions. Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies. Low-cost FDA approved Humira biosimilars We refer to prescription and over-the-counter (OTC) drugs as brand and generic drugs. However, not all biosimilars are interchangeable.

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Pharmacy Times

FEBRUARY 23, 2024

Dedicated clinical trials in IBD cohorts that scrutinized biosimilar use in real-world clinical practice have direct implications on decision making.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved? Stelara biosimilars in the US market The first Stelara biosimilars are expected to enter the US market in 2025. “We

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Outsourcing Pharma

FEBRUARY 6, 2024

Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.

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European Pharmaceutical Review

AUGUST 16, 2023

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®.

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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.,

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European Pharmaceutical Review

APRIL 6, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI , a biosimilar referencing Soliris (eculizumab), also known as SB12. We are pleased to see EPYSQLI becoming our first biosimilar in haematology to be recommended for approval in Europe.

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European Pharmaceutical Review

NOVEMBER 15, 2022

The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access.

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The Checkup by Singlecare

NOVEMBER 6, 2023

Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. Manufactured by Amgen, the biosimilar—which is like a generic for biologic medications—was approved to treat inflammatory conditions like plaque psoriasis or ulcerative colitis. How much will Wezlana cost?

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Fierce Healthcare

JULY 5, 2023

Hospital outpatient departments are marking up the prices for biologic medicines more than physician offices, particularly for “innovator biologics” that have clinically equivalent and lower cost a | Consistently higher markups among hospital outpatient departments hamstring potential savings payers may hope to see down the line as more biosimilars (..)

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European Pharmaceutical Review

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. Interchanging biosimilars is an acceptable practise already used by many Member States.

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The Checkup by Singlecare

DECEMBER 26, 2023

With insulin now being categorized as a biologic product, the development of insulin biosimilars has gained momentum. These biosimilar products are highly similar to their reference insulin products and have no clinically meaningful differences in terms of safety and efficacy. What are insulin biosimilars?

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Hospital Pharmacy Europe

MAY 30, 2023

Discover a range of audio and visual resources to support learning needs and improve understanding of the key issues surrounding biosimilars. The post Fundamentals of biosimilars: educational resources appeared first on Hospital Pharmacy Europe.

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Hospital Pharmacy Europe

OCTOBER 9, 2023

This brief pilot study report details a small retrospective study undertaken in a UK hospital that looked at the implications of removing prior authorisation (Blueteq) for the biosimilars adalimumab or infliximab when used in inflammatory bowel disease. 1 ​Remission can be determined as either clinical or endoscopic.

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Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Humoral Hypercalcemia of Malignancy.

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Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Post Menopausal Osteoporosis.

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Pharmaceutical Technology

MARCH 18, 2024

Adalimumab biosimilar is under clinical development by Biocon and currently in Phase III for Plaque Psoriasis (Psoriasis Vulgaris).

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Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Giant Cell Tumor Of Bone.

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Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Bone Metastasis.

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Pharmaceutical Technology

MARCH 18, 2024

Denosumab biosimilar is under clinical development by Celltrion and currently in Phase I for Osteoporosis.

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Pharmaceutical Technology

FEBRUARY 8, 2024

Prabotulinumtoxin A biosimilar is under clinical development by AEON Biopharma and currently in Phase II for Spasmodic Torticollis (Cervical Dystonia).

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Pharmaceutical Technology

FEBRUARY 15, 2023

JSR Life Sciences’ business unit Similis Bio is planning to collaborate with Novel351k for the development of three biosimilar programmes targeting cancer and autoimmune diseases. This will lead to pharmacokinetics/pharmacodynamic clinical trials.

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Pharmaceutical Technology

FEBRUARY 7, 2024

Trastuzumab biosimilar is under clinical development by Qilu Pharmaceutical and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer).

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Pharmaceutical Technology

FEBRUARY 23, 2023

Ranibizumab biosimilar is under clinical development by Generium and currently in Phase III for Wet (Neovascular / Exudative) Macular Degeneration. GlobalData’s report assesses how Ranibizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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PharmaShots

MAY 30, 2023

Shots: The EC has granted marketing authorization for Epysqli, a biosimilar referencing Soliris (eculizumab) for the treatment of adult and children’s patients with PNH The approval was based on a totality of evidence incl. analytical, in vitro non-clinical data, and clinical data.

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Pharmaceutical Technology

FEBRUARY 21, 2024

Denosumab biosimilar is under clinical development by Lupin and currently in Phase III for Post Menopausal Osteoporosis.

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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. Boan Biotech has announced that the first patient has been enrolled in its phase 3 trial of its Nivolumab injection (BA1104) in China.

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Pharmaceutical Technology

JUNE 7, 2023

Rituximab biosimilar is under clinical development by Celltrion and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).

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Pharmaceutical Technology

FEBRUARY 8, 2024

Prabotulinumtoxin A biosimilar is under clinical development by AEON Biopharma and currently in Phase II for Migraine.

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Pharmaceutical Technology

JANUARY 4, 2024

Palivizumab biosimilar is under clinical development by Mabxience Holding and currently in Phase I for Respiratory Syncytial Virus (RSV) Infections.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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