Biosimilars – Talk Bio

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

2 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

2 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

6 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

Johnson & Johnson Sues Samsung Bioepis Over Alleged Stelara Biosimilar Contract Breach

6 months ago talkbio0Tagged Bioepis, Biosimilars, Contract agreement, Johnson and Johnson, Pyzchiva, Samsung, Stelara, ustekinumab

Johnson & Johnson, Samsung Bioepis, Stelara, biosimilar, lawsuit, contract breach, ustekinumab, Pyzchiva

Roivant Halts Lung Disease Drug Development as Bio-Thera and Intas Forge Biosimilar Partnership

7 months ago talkbio0Tagged Accord BioPharma, Bio-Thera, Biopharma, Biosimilars, golimumab, Intas, namilumab, Roivant, Sarcoidosis, Pulmonary, Solutions

Roivant Sciences, namilumab, pulmonary sarcoidosis, Bio-Thera Solutions, Intas Pharmaceuticals, golimumab biosimilar, BAT2506, Accord BioPharma

Amgen and Celltrion Reach Settlement in Denosumab Patent Litigation, Paving Way for Mid-2025 Biosimilar Launch

7 months ago talkbio0Tagged amgen, Biosimilars, Celltrion, denosumab, launch, Legal patent, Litigation, settlement

Amgen, Celltrion, denosumab, patent litigation, biosimilar, settlement, launch date

Samsung Biologics Achieves Record Revenue and Secures Largest Contract to Date

7 months ago talkbio0Tagged Biological Factors, Biosimilars, CDMO, Contract agreement, Drug Industry, Largest, Revenue, Samsung

Samsung Biologics, Record Revenue, Largest Contract, Biosimilars, CDMO, Pharmaceutical Industry

Biopharmaceutical Manufacturing and Emerging Trends in 2024: A Global Outlook

8 months ago talkbio0Tagged 2024, Biopharmaceutical manufacturing, Biosimilars, Biotechnology, Cells, Drug Discovery, gene therapy, innovations, Precision Medicine, trends qualifier

Biopharmaceutical manufacturing, 2024 trends, personalized medicine, AI-driven drug discovery, biosimilars, cell and gene therapies, biotechnology innovations.