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Gedeon Richter
NEWS

Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva) 

Shots:  The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab)  Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone  Junod & Yaxwer are mAbs (IgG2) that block RANKL, preventing osteoclast activation   Ref: Gedeon Richter | Image: Gedeon Richter…
April 25, 2025

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Biocon Biologics
NEWS

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots: Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26 Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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Celltrion
NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was…
April 15, 2025

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Intas & Coherus
NEWS

Intas Pharmaceuticals Acquires Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)

Shots: Intas has acquired Coherus’ Udenyca business (incl. prefilled syringe, autoinjector & on-body injector), a biosimilar version of Amgen’s Neulasta (pegfilgrastim) via 2024 asset purchase agreement; Accord BioPharma (Intas’ US specialty division) will handle Udenyca’s US business As per the deal, Coherus received $483.4M upfront in cash, incl. $118.4M for Udenyca inventory, with an additional…
April 15, 2025

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Accord Healthcare
NEWS

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025 Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…
April 3, 2025

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Biogen & Organon
NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…
April 2, 2025

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Celltrion
NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program 

Shots:  Celltrion announced that Steqeyma (ustekinumab-stba), a biosimilar to Stelara, has been added to the Costco Member Prescription Program. It was launched on Mar 12, 2025. Celltrion's adalimumab-aaty was added to the program in Aug 2024   Steqeyma will be available in the US from Costco Specialty Pharmacies on Apr 1, 2025, for self-funded employer plans,…
March 28, 2025

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