Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
|Articles|June 28, 2007
EMEA Recommends Epoetin Alfa Biosimilars for Approval
Author(s)Pharmaceutical Technology Editors
London, UK (June 22)-The competition between biosimilars and branded drugs intensified this week thanks to favorable reviews of three biosimilar products for a popular treatment for anemia.
Advertisement
London, UK (June 22)-The competition between biosimilars and branded drugs intensified this week thanks to favorable reviews of three biosimilar products for a popular treatment for anemia. During a June 18–21 meeting, the European Medicines Agency’s
Epoetin alfa is an injectable protein drug for treating anemia associated with chronic kidney disease and in oncology patients. It also is the active ingredient in Epogen (epoetin alfa recombinant) from
Advertisement
Related to this article
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
Advertisement
Advertisement