Biosimilars – Talk Bio

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

4 days ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

Sandoz Launches Tyruko (Natalizumab-Sztn), First Tysabri Biosimilar, in US After JCV Assay Delays

4 days ago talkbio0Tagged Approved, Biological Assay, Biosimilars, JC Virus, JCV, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, Polpharma Biologics, Progressive, sandoz, Tyruko, Tysabri, United States Food and Drug Administration

Sandoz; Tyruko; Tysabri biosimilar; natalizumab-sztn; multiple sclerosis (MS); biosimilar launch; JCV assay; progressive multifocal leukoencephalopathy (PML); FDA approval; Polpharma Biologics

FDA Reduces Regulatory Red Tape for Biosimilars

3 weeks ago talkbio0Tagged approvals, Biosimilars, faster, Financial cost, regulatory changes, United States Food and Drug Administration

FDA; biosimilars; regulatory changes; cost reduction; faster approvals

Unlocking Access: Navigating Pharma’s Regulatory Crossroads – Recent Updates (2025)

1 month ago talkbio0Tagged Access, access strategy, Biosimilars, CRLs, drug importation, drug price, executive actions, Market, Patient access, pharmaceutical regulation, United States Food and Drug Administration

pharmaceutical regulation; market access; drug pricing; FDA transparency; biosimilars; executive actions; market access strategy; drug importation; CRLs; patient access

Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe

2 months ago talkbio0Tagged Biological Factors, Biosimilars, CDMO, Contract agreement, Digital innovation, Europe, Gdańsk, Guanosine Monophosphate, Manufacturing, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Rezon Bio, United States Food and Drug Administration, Warsaw-Duchnice

Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA

Celltrion Acquires Eli Lilly’s New Jersey Manufacturing Site for $330 Million

2 months ago talkbio0Tagged Acquisition, Biopharmaceutical manufacturing, Biosimilars, Celltrion, Contract agreement, eli lilly, Investments, Jersey site, supply chain, US tariffs

Celltrion; Eli Lilly; New Jersey site; acquisition; biopharmaceutical manufacturing; US tariffs; contract manufacturing; supply chain; biosimilars; investment

Merck Wins FDA Approval for Subcutaneous Keytruda as Exclusivity Challenges Approach

2 months ago talkbio0Tagged Approved, Biosimilars, checkpoint inhibitors, Immunotherapy for cancer, Keytruda, Keytruda Qlex, Merck, patent expiration, Solid Neoplasm, Subcutaneous Injections, United States Food and Drug Administration

Merck; Keytruda; subcutaneous injection; FDA approval; Keytruda Qlex; patent expiration; biosimilars; checkpoint inhibitors; solid tumors; cancer immunotherapy

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

2 months 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

3 months 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

4 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