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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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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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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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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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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Big Molecule Watch

DECEMBER 14, 2023

announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023. The post Recent Biosimilar Approvals appeared first on Big Molecule Watch.

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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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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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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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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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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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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

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 278

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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Biosimilars Diabetes 86

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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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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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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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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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

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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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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PharmaShots

APRIL 10, 2023

Shots: With an incurable nature and hefty medication costs, diabetes mellitus remains a global health concern and the seventh leading cause of death across the world. Diabetes, aka diabetes mellitus is a condition that arises when the pancreas fails to produce enough insulin or the cells of the body do not respond to the insulin produced.

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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

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

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

MARCH 15, 2024

Thanks to the rising use of various blockbuster drugs, but particularly the so-called GLP-1 medications for treating obesity and diabetes, the outlook for earnings for the pharmaceutical industry is positive over the next 12 to 18 months , according to Moody’s Investor Services.

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PharmaShots

FEBRUARY 1, 2023

Ximluci is expected to be available in the UK in 2023 The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults.

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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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Express Pharma

OCTOBER 6, 2023

Biocon has signed a partnership agreement with Juno Pharmaceuticals, a specialty pharmaceutical company in Canada, for the commercialisation of its vertically integrated, complex formulation, Liraglutide, a drug-device combination for the treatment and management of Type 2 diabetes and obesity.

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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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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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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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Pharmaceutical Technology

SEPTEMBER 7, 2022

The diabetic macular oedema (DME) market is anticipated to reach values of $11.1bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan). Ranibizumab biosimilars are also set to enter the DME market during the forecast period, which will undoubtedly compete with their parent drug, Lucentis.

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Big Molecule Watch

NOVEMBER 20, 2023

Biocon Biologics receives approval in the UK for Aflibercept biosimilar : On November 13, 2023, Biocon Biologics Limited announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for YESAFILI, a biosimilar aflibercept.

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Biosimilars Diabetes 62

Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health.

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Pharmacy Times

MAY 3, 2023

Pharmacists will play a growing role in the use of biosimilars and guiding patients through the switching process.

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