Biosimilars – Talk Bio

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

1 week 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

4 weeks 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

1 month 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

1 month 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

2 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

3 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

4 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.

6 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

8 months ago talkbio0Tagged 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