FDA issued Teva Pharmaceuticals a "complete response" on the BLA for Neutroval, its biosimilar formulation of Amgen's granulocyte colony-stimulating factor Neupogen for chemotherapy-induced neutropenia. Teva announced Sept. 30 that the agency had asked for "several items" but not for additional pre-market clinical trials, demonstrating that as pharmas explore regulatory pathways for biosimilars, going the full BLA route to approval will not guarantee a smooth review (1"Biosimilar Road Bump: Teva Filgrastim's Complete Response Shows Even Full BLAs Can Stumble," "The Pink Sheet" DAILY, Oct. 1, 2010). The action letter was not entirely unexpected, given that both Teva and FDA are finding their way in the U.S. biosimilar space. FDA has scheduled a public hearing for Nov. 2-3 to gather input on implementing the legislation that enabled an approval pathway for generic biologics in this country. Meanwhile, Teva said it will work with the agency to find a pathway to approval, which could serve more than one objective. The Israeli biopharma is also working on a biosimilar of Amgen's Neupogen follow-on Neulasta (pegfilgrastim). Neutroval is already marketed in Europe as TevaGrastim. The European approval, however, doesn't seem to have made a big dent in Amgen's market share for the veteran product. According to Robert W. Baird analyst Raymond Christopher, Amgen's ex-U.S. market share is only off about 4% due to biosimilars, and its U.S. share "could prove similarly resilient," particularly because Amgen "fully intends to defend this franchise" through patent litigation
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
