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NEWS

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Shots: Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
January 14, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:     Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis Read More: Oculis PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential…
January 10, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)

Shots: Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn's disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent…
January 8, 2025

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NEWS

GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)

Shots: GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab) The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations SPD8 is under P-III…
January 7, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (December 30th, 2024 – January 03rd, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:     Novartis Reports Data from P-III (STEER) Study of Onasemnogene Abeparvovec to Treat Children and Young Adults with Spinal Muscular Atrophy (SMA) Read More: Novartis CARsgen Therapeutics Reports Topline Results from P-II…
January 3, 2025

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NEWS

Bio-Thera Solutions and SteinCares Add Another Biosimilar, Expanding their Alliance

Shots:  Bio-Thera Solutions has expanded its collaboration with SteinCares, granting it exclusive rights to market a third biosimilar in Brazil and the LATAM region  Bio-Thera will handle development, the US FDA & the EMA submissions to support LATAM regulatory filings & commercial supply of each biosimilar from its Chinese manufacturing facilities  SteinCares will utilize its…
December 16, 2024

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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
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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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