Pharmacy Times

OCTOBER 2, 2024

In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.

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Big Molecule Watch

MAY 19, 2023

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). BA5101 is a biosimilar of Trulicity, used for glycemic control in adults with insufficiently controlled type 2 diabetes mellitus.

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Biosimilars Diabetes 70

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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Biosimilars Diabetes 98

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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Express Pharma

SEPTEMBER 20, 2023

Biocon Biologics has received the European Commission (EC) granted marketing authorization in the European Union (EU) for YESAFILI, a biosimilar of Aflibercept. The post Biocon Biologics gets EC approval for YESAFILI, biosimilar Aflibercept appeared first on Express Pharma. Aflibercept had EU brand sales of approximately $1.8

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Biosimilars Diabetes 105

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. A biosimilar for biologic ophthalmic treatments.

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Biosimilars Diabetes 104

STAT

NOVEMBER 18, 2022

The first therapy that delays the onset of type 1 diabetes received approval from the U.S. million people have type 1 diabetes in the U.S., according to the American Diabetes Association, including 244,000 children and adolescents. Type 1 affects 8% of everyone with diabetes. Food and Drug Administration , CNN tells us.

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Express Pharma

MAY 22, 2024

Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. ” Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics said, “Biosimilars are crucial for making healthcare more affordable and accessible.”

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Big Molecule Watch

AUGUST 6, 2024

Midas Pharma GmbH’s Ranibizumab Midas for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularization.

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Biosimilars Diabetes 57

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.

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Biosimilars Diabetes Immunity Immunization 57

PharmExec

JANUARY 22, 2024

The biosimilar Cimerli carries the interchangeability designation for the treatment of wet age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, myopic choroidal neovascularization, and diabetic retinopathy.

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Biosimilars Diabetes 40

Pharmaceutical Business Review

APRIL 17, 2024

This partnership is set to enhance the treatment options available to diabetes patients in Brazil. It develops, manufactures and commercialises complex biotech and biosimilar drug products at its production facility in Nova Lima. million cases by 2030, according to the Diabetes Atlas of the International Diabetes Federation (IDF).

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Diabetes Biosimilars 59

pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. Biosimilars marketed in the US typically have list prices 15% to 35% lower than their reference products at launch.

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Biosimilars Diabetes 98

Pharmacy Times

JANUARY 3, 2024

Liraglutide, a glucagon-like peptide 1 receptor agonist, has shown a clinically and significant reduction in glycated hemoglobin for those with type 2 diabetes.

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Diabetes Biosimilars 59

Big Molecule Watch

APRIL 5, 2023

On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. and Europe later this year.

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Biosimilars Diabetes 57

Express Pharma

NOVEMBER 13, 2023

Biocon Biologics, a subsidiary of Biocon announced that MHRA, Medicines and Healthcare products Regulatory Agency in the UK, has granted marketing authorisation for YESAFILI, a biosimilar of Aflibercept. The post Biocon Biologics gets MHRA approval for YESAFILI, biosimilar Aflibercept appeared first on Express Pharma.

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Biosimilars Diabetes 52

pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

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Express Pharma

JULY 23, 2023

Biocon Biologics, a subsidiary of Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar.

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STAT

APRIL 4, 2024

… The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective for diabetes and obesity, but is also showing early potential to help with conditions involving the brain, such as mental health disorders, Alzheimer’s, and even, as new study results suggest — Parkinson’s disease , STAT writes.  In

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pharmaphorum

AUGUST 3, 2022

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. The post Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod appeared first on.

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Express Pharma

DECEMBER 19, 2023

Insuquick is a “Make in India” product and is available in all metros, and tier I/II cities USV has announced a partnership with Biogenomics to launch Insuquick, a biosimilar insulin aspart for people with diabetes In India. We have collaborated with Biogenomics to provide global-quality insulin aspart for our people with diabetes.

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Diabetes Biosimilars 101

STAT

JANUARY 4, 2024

… Starting April 1, CVS Health will no longer offer AbbVie’s Humira to patients in its commercial prescription plans and, instead, will direct them to biosimilar versions of the anti-inflammatory drug that became available last year , Bloomberg News writes.

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Biosimilars Diabetes 301

Big Molecule Watch

JUNE 30, 2023

(“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s now owns the rights to Viatris’s aflibercept biosimilar. s submission in October 2021.

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Biosimilars Diabetes 62

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. Buy the report here.

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Pharmaceutical Technology

NOVEMBER 18, 2023

Aflibercept Biosimilar. is a fusion protein commercialized by Celltrion, with a leading Phase III program in Diabetic Macular Edema.

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Biosimilars Diabetes 40

pharmaphorum

APRIL 13, 2022

It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone. In recent years, there have been more developments in the area of diabetes management, with the emergence of metformin and more recently semaglutide and dulaglutide.

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Drug Pricing Diabetes Biosimilars 130

Big Molecule Watch

JUNE 7, 2024

FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. s OPUVIZ (aflibercept-yszy) as interchangeable biosimilars to Regeneron Pharmaceutical, Inc.’s and Biocon Biologics, Inc.’s

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Biosimilars Diabetes Labelling 52

pharmaphorum

SEPTEMBER 20, 2021

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.

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Big Molecule Watch

DECEMBER 21, 2023

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 10,888,601 (“the ’601 Patent”), challenging claims directed to methods of treating diabetic macular edema (“DME”) and diabetic retinopathy (“DR”).

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Biosimilars Diabetes 62

Express Pharma

APRIL 18, 2024

Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at their production facility in Nova Lima.

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PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. Sandoz Reports Real World Study Results of GP2013 (biosimilar, rituximab) for the Treatment of Rheumatoid Arthritis Date- May 08, 2023 Product: GP2013 (biosimilar, rituximab) The study incl. 84% vs 64%) & 2yr. (60%

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Biosimilars Packaging Diabetes Pharmaceutical Companies 40

pharmaphorum

AUGUST 17, 2021

Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on the safety issue, with Beovu (brolucizumab) found to be roughly equivalent to Bayer and Regeneron’s Eylea (aflibercept) when it came to inflammatory reactions in the eye. of Beovu patients, compared to 1.7%

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Diabetes Biosimilars 98

STAT

OCTOBER 23, 2024

Amgen will launch its biosimilar version of a blockbuster Regeneron Pharmaceutical drug for an eye disease following a U.S. Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. appeals court ruling in its favor , Reuters writes.

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Compounding Compounding Pharmacies Biosimilars Documentation 248

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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Biosimilars Diabetes Immunity Immunization 40

pharmaphorum

AUGUST 23, 2021

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. The post Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz appeared first on. billion for Roche and $1.9

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Biosimilars Diabetes 40

Big Molecule Watch

FEBRUARY 6, 2024

biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. On January 22, 2024, Sandoz announced its plans to acquire the U.S. Coherus”) for an upfront cash purchase payment of USD 170 million. CIMERLI solution for injection 0.3 mg (6 mg/mL) and 0.5

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Biosimilars Diabetes 67

Pharmacy Times

SEPTEMBER 19, 2023

Insulin glargine-yfgn is more affordable than the reference product and patients do not require prescriber authorization switch.

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Diabetes Biosimilars 59