Progress on biogenerics inches along, as evidenced by deal between Barr Pharmaceuticals and PLIVA giving Barr rights to market Pliva's version of G-CSF in North America, and by the recent well-attended FDA workshop on follow-on proteins (FOPs). Barr/PlLIVA, the first company/company deal in this field in months indicates that companies still see opportunity despite last year's regulatory setbacks. The FDA workshop, while far from conclusive, hinted at a softening of positions by both opponents and proponents of biogenerics; at least they're talking the same language.
Barr Pharmaceutical Inc.'s recent deal with Croatian firm Pliva DD to develop and market a generic version of G-CSF (granulyte colony stimulating factor; Amgen Inc. 's filgrastim (Neupogen)) is further indication that momentum is slowly but surely building for creation of a US regulatory pathway for follow-on proteins (FOPs), or biogenerics. [See Deal]
While not disclosing details, Barr and Pliva said that they will split responsibilities, with Pliva developing the product—it is Pliva's...
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