Biosimilars – Talk Bio

mAbxience and HP Drive the Use of Artificial Intelligence in Biomanufacturing and Biosimilar Development

3 days ago talkbio0Tagged Artificial Intelligence, Biological Factors, biomanufacturing, Biosimilars, development aspects, digital twin, Fresenius, Hereditary pancreatitis, mAbxience, Monoclonal Antibodies, Neural Network Simulation

mAbxience; HP; artificial intelligence; biomanufacturing; biosimilar development; digital twin; monoclonal antibodies; neural network models; biologics; Fresenius

Biocon Biologics Secures Market Entry Date for Denosumab Biosimilars in Europe and Global Markets

5 days ago talkbio0Tagged Amgen settlement, Biocon Biologics, Biosimilars, biosimilars approval, bone health, Commission, denosumab, entry - ActRelationshipCheckpoint, Europe market, European (ethnic group), Evfraxy, Neoplasms, Vevzuo

Biocon Biologics; Denosumab biosimilars; Vevzuo; Evfraxy; Europe market entry; Amgen settlement; biosimilars approval; European Commission; bone health; oncology

Sandoz Launches Afqlir (Aflibercept) in Europe, Increasing Access to Affordable Retinal Disease Treatment

2 weeks ago talkbio0Tagged affordable treatment, aflibercept, Afqlir, Age related macular degeneration, anti-VEGF therapies, Biosimilars, Blindness, Europe, European Commission approval, Exudative age-related macular degeneration, Eylea, Neovascular, Retinal Diseases, sandoz

Sandoz; Afqlir; aflibercept; biosimilar; retinal diseases; neovascular age-related macular degeneration (nAMD); European Commission approval; Eylea; anti-VEGF therapies; affordable treatment; vision loss; Europe

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

3 weeks 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

3 weeks 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

1 month 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)

2 months 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

3 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