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NEWS

STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU

Shots:    The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions   Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply…
July 22, 2024

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Celltrion
NEWS

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots:  Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)  The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…
May 23, 2024

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NEWS

Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology 

  Shots:  The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV)  The approval was supported by analytical, nonclinical & clinical data…
May 21, 2024

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NEWS

Alvotech Collaborates with Dr. Reddy’s to Commercialize AVT03 (Biosimilar, Prolia & Xgeva) 

  Shots:  Alvotech & Dr. Reddy’s have signed a license & supply agreement to commercialize AVT03 under which Alvotech will handle the development & manufacturing activities. Dr. Reddy will get regulatory & commercial rights exclusively in US and semi-exclusively in the EU & UK   Alvotech will receive an upfront, regulatory & commercial milestones as well as…
May 21, 2024

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Teva and Alvotech
NEWS

Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications 

Shots:  The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US  The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US  The approval was based…
May 20, 2024

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NEWS

Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications 

Shots:  Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications  As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development &…
April 4, 2024

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Insights+ Key Biosimilars Events of October 2023
INSIGHTS+

Insights+ Key Biosimilars Events of October 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency  Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…
November 1, 2023

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VIEWPOINTS_John Gabrielson_2023
VIEWPOINTS

John Gabrielson SVP, Biosimilars & Head of Business of Similis Bio (JSR Life Sciences) Shares Insights on the Partnership with Blau Farmaceutica to Co-Develop Four Biosimilar Programs

Shots:  John spoke about the agreement between Similis Bio (a biosimilar partner and affiliate company of JSR) and Blau Farmaceutica to develop products and license IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders Under the collaboration, Similis Bio will provide full processes and associated IP for tech transfer to Blau…
February 2, 2023

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Insights+ Key Biosimilars Events of April 2021
INSIGHTS+

Insights+ Key Biosimilars Events of April 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of April, Biocon and Viatris received EC's approval for…
May 6, 2021

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