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.

Biosimilars 72

Biosimilars Labelling Diabetes 72

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.”

Biosimilars 52

Biosimilars Diabetes Dosage 52

Big Molecule Watch

FEBRUARY 6, 2024

On January 22, 2024, Sandoz announced its plans to acquire the U.S. biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. According to Sandoz, “closing is anticipated in 1H 2024, subject to standard conditions and approval.” Coherus”) for an upfront cash purchase payment of USD 170 million.

Biosimilars 69

Biosimilars Diabetes 69

Big Molecule Watch

NOVEMBER 27, 2024

On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. OPUVIZ is the second EC-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership.

Biosimilars 40

Biosimilars Diabetes 40

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”).

Biosimilars 64

Biosimilars Diabetes 64

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. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s

Biosimilars 40

Biosimilars Diabetes Labelling 40

pharmaphorum

JANUARY 13, 2023

.” He added that people from low-income households and some racial and ethnic groups are disproportionately impacted by the practices, including Hispanic and Black people, who are much more likely to be diagnosed with diabetes than non-Hispanic white people – and much more likely to die as a result of complications.

Diabetes 105

Diabetes Drug Pricing Biosimilars 105

Big Molecule Watch

DECEMBER 28, 2023

As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. At trial, Regeneron asserted infringement of claims 6 and 25 of U.S.

Biosimilars 69

Biosimilars Diabetes 69

Express Pharma

NOVEMBER 1, 2024

The Union Health Ministry received an allocation of about Rs 90,650 crores in the recent budget of 2024-25, a 12.5 Establishing Centers of Excellence and leveraging artificial intelligence for pharma research can advance India’s capabilities in NCEs, biologics, and biosimilars, placing it at the forefront of global pharma innovation.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Biosimilars Communication Diabetes 105

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

Biosimilars 52

Biosimilars Labelling Diabetes Compounding 52

pharmaphorum

JUNE 1, 2021

Protection has already expired in the US – where it is sold by Roche – but biosimilars are not expected to reach the US market until the latter half of this year. $8 8 billion blockbuster Eylea meanwhile is due to lose protection in 2024, so the wet AMD market is set for a major shake-up in the next few years. billion or more at peak.

Biosimilars 66

Biosimilars Diabetes 66

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Indication: Type 2 Diabetes Mellitus Victoza is a non-insulin, anti-diabetic medicine used for the treatment of type 2 diabetes and to reduce the risk of cardiovascular events associated with the disease.

Biosimilars 49

Biosimilars Diabetes Chemotherapy Immunity 49

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

Biosimilars 56

Biosimilars Labelling Diabetes 56

Big Molecule Watch

JULY 9, 2024

announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is the third biosimilar referencing STELARA to be approved by the FDA, following Amgen’s WEZLANA (ustekinumab-auub), approved in October 2023, and Alvotech’s and Teva’s SELARSDI (ustekinumab-aekn), approved in April 2024.

Biosimilars 49

Biosimilars Diabetes 49

pharmaphorum

MARCH 3, 2022

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs. Cheaper options are meanwhile becoming available.

Biosimilars 52

Biosimilars Diabetes Mayo Clinic 52

PharmaShots

APRIL 3, 2023

old, for use by women with diabetes who are pregnant & for wear time of up to 15 days. The results also showed a reduction in risk of hospitalization for any cause with 14% relative risk reduction (24.8 events/100 patient-yrs.) The authorization incl. 4 approved medicines across solid tumors & hematologic malignancies, incl.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

pharmaphorum

MAY 13, 2022

It has filed a lawsuit that accuses the drugmakers and pharmacy benefit managers Express Scripts, Caremark and OptumRx of conspiring to manipulate and inflate insulin prices in the state, inflating their profits and making the drugs unaffordable for many diabetics. Some companies are already taking steps to provide lower-cost products.

Diabetes 59

Diabetes Biosimilars Drug Pricing 59

pharmaphorum

MARCH 23, 2022

If passed, the Affordable Insulin Now Act would apply the cap across both private health insurance and Medicare plans, and according to Schumer would cut the cost of a 30-day supply of insulin for people with diabetes from a current range of $200 to $600 per person. Some companies are already taking steps to provide lower-cost insulin.

Diabetes 75

Diabetes Biosimilars Drug Pricing 75

STAT

JULY 15, 2024

In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.

Drug Pricing 239

Drug Pricing Biosimilars Diabetes 239

Express Pharma

NOVEMBER 27, 2024

Biocon Biologics shared the progress of the ongoing ‘Embedding Specialist Nurses in Diabetes Care’ project undertaken in collaboration with Diabetes Africa and St Paul’s Hospital Millennium Medical College in Ethiopia. Diabetes contributes to nearly 2 per cent of all deaths in the country*. Dr Sisay S.

Diabetes 104

Diabetes Biosimilars Hospitals 104