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Biocon Biologics
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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 H2’26Yesafili’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
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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
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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 businessAs 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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Biogen & Organon
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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 USAs per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestonesTofidence 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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Bio-Thera and Dr. Reddy's
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Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia 

  Shots: Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab) As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…
March 28, 2025

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