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A House subcommittee on health is considering holding a hearing on follow-on biologics — a move that could put more pressure on regulators to complete a regulatory pathway for the products.
Follow-on biologics are still at least three years away from becoming a reality in the U.S., according to Barr Laboratories CEO Bruce Downey, who said he remains confident the FDA will establish a pathway for biogenerics.
Acting FDA Commissioner Lester Crawford believes the science is available for the FDA to move forward on follow-on biologic products, but he told a recent industry conference that the FDA still has many kinks to work out on the regulatory front.
Although the FDA has made little headway on developing an approval pathway for follow-on biologics, pharmaceutical firms aren’t sitting on their hands waiting for the agency to act.
In a December 2004 report, the Generic Pharmaceutical Association (GPhA) offered answers to questions that the FDA posed in a September 2004 workshop on the scientific challenges of creating follow-on biologics, or biogenerics.
Despite comments in a recent docket submission to the FDA that appear to indicate some softening on the topic, a representative of the trade group Biotechnology Industry Organization (BIO) says the organization is not relaxing its position on an abbreviated approval process for generic biologics.
European health regulators recently issued a new guideline and four concept papers describing the general principles and requirements for approving follow-on biologics.
The FDA should assemble a task force consisting of agency experts to establish parameters for the approval of generic biologics, according to a trade group representing generic drugmakers.
As the generic drug industry urges the FDA to become more proactive in the generic biologics debate, a key brand firm says scientific advances have made it possible for drugmakers to reproduce follow-on biopharmaceutical products with the same measurable proprieties as those of the innovator firm.
The FDA has issued a final guidance document that details the vaccine labeling review process, describes the agency’s review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act (NCVIA) and discusses the type of data FDA examines when determining the adequacy of vaccine labeling.