Biosimilars Diabetes Labelling 
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.
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
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
FDA Law Blog: Biosimilars
NOVEMBER 14, 2024
As reported in a recent publication (citations omitted): An estimated 129 million people in the US have at least 1 major chronic disease (eg, heart disease, cancer, diabetes, obesity, hypertension) as defined by the US Department of Health and Human Services. Undoubtedly, the public health and economic toll of chronic disease is staggering.
PharmaShots
JUNE 28, 2023
Regeneron is jointly developing aflibercept along with Bayer Ref: Regeneron | Image: Regeneron Related News:- Alvotech Entered into an Exclusive Agreement with Polifarma to Commercialize AVT06, a Proposed Biosimilar to Eylea (aflibercept) in Turkey PharmaShots! Your go-to media platform for customized news ranging for multiple indications.
European Pharmaceutical Review
FEBRUARY 22, 2023
1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. Diabetes Therapy. The Business Research Company. 2019;10(2):437–49.
pharmaphorum
SEPTEMBER 9, 2022
The two studies – in wet age-related macular degeneration (AMD) and diabetic macular oedema (DME) – showed the 12- and 16-week Eylea (aflibercept) regimens were non-inferior to the currently approved 8-week dosing, reducing the number of injections into the eye needed by patients with the sight-robbing diseases. .”
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