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While generic drugmakers are leading the charge for follow-on biologics, existing biotech brand firms likely will be the first to go after the nearly $10 billion worth of biologic products going off patent in the next few years, experts say.
All interested parties should have the chance to participate in a public process before the FDA develops a follow-on biologics initiative, argued a leading biotechnology industry trade group.
Generic biologics can be developed using available raw materials, and the FDA can approve the products as fully substitutable for their brand equivalents, according to Barr Pharmaceuticals’ executives, who challenged some common perceptions about the complex molecules.
FDA regulations allow for authorized generics, and any move to keep them off the market until another generic firm’s 180-day exclusivity period expires would violate federal drug law, argued brand firm Johnson & Johnson (J&J).
Mylan Pharmaceuticals has sued the FDA over its decision to grant Johnson & Johnson’s (J&J’s) subsidiary Janssen Pharmaceutica six months of pediatric exclusivity on its lucrative pain drug patch Duragesic — a move that will delay generic entry until January 2005.
The FDA will release its long-awaited guidance on the scientific challenges to creating follow-on biologics after it holds a workshop later this summer or early fall to address the issue, the acting FDA chief told lawmakers recently.
Manufacturers of digoxin elixirs can continue marketing them without agency-approved new drug applications for an additional six months to ensure continued availability of the products, the FDA announced.
A bill approved by the House Appropriations Committee last week contains a provision that would prohibit the FDA from spending federal money to disrupt drug importation.