Biosimilars – Talk Bio

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

1 week ago talkbio0Tagged Approved, Biosimilars, Enzeevu, Eylea, launch, Ophthalmology specialty, Patent Settlement, Regeneron, sandoz, United States, United States Food and Drug Administration

Regeneron; Sandoz; Eylea; Enzeevu; biosimilar; aflibercept; patent settlement; FDA approval; U.S. launch; ophthalmology

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

4 weeks ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

J&J’s Stelara Revenue Plummets as Biosimilar Competition Intensifies in 2025

2 months ago talkbio0Tagged Autoimmune Diseases, Benefit, Biosimilars, drug price, formulary exclusion, Johnson & Johnson, manager, Pharmaceutical Services, Revenue Decline, Stelara, ustekinumab

Stelara; Johnson & Johnson; ustekinumab; biosimilars; revenue decline; Q2 2025; pharmacy benefit managers; formulary exclusion; drug pricing; autoimmune disease

CHMP Recommends Five New Drugs and Reviews Eli Lilly’s Kisunla

3 months ago talkbio0Tagged Biosimilars, CHMP, eli lilly, Hyperphosphatemia (disorder), Kisunla, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Myopia, regulatory review

CHMP; EMA; new drug approvals; Eli Lilly; Kisunla; biosimilars; hyperphosphatemia; myopia; March 2025; regulatory review

Sandoz Challenges Amgen in Antitrust Lawsuit to Launch Enbrel Biosimilar in the U.S.

5 months ago talkbio0Tagged amgen, Approved, Biological Factors, Biosimilars, competition, Enbrel, Erelzi, etanercept, Legal patent, Market, Rheumatoid Arthritis, sandoz, United States, United States Food and Drug Administration

Sandoz, Amgen, Enbrel, Erelzi, antitrust, biosimilar, etanercept, patent thicket, U.S. market, rheumatoid arthritis, competition, biologics, FDA approval.

Oncology Market in 2025: Innovation, Growth, and Patient-Centric Care

7 months ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, Biosimilars, Clinical Trial Design, Combined, Immunotherapy for cancer, Neoplasms, Personalized cancer care, Precision Medicine, targeted therapies

Cancer immunotherapy, Targeted therapies , Precision medicine, AI in oncology, Combination treatments, Biosimilars, Clinical trial design, Personalized cancer care