"We strongly feel that not only should the FDA do guidance prior to approving, but also require clinical evidence."
Walter Moore, VP of government affairs for Genentech, said that innovator companies are less concerned with competition from generic manufacturers of follow-on biologics than they are about patient safety and data exclusivity. "We strongly feel that not only should the FDA do guidance prior to approving, but also require clinical evidence." During a teleconference on follow-on biologics, sponsored by Avalere Health, Moore said that follow-on biologics are difficult therapies to produce and even though a biologic has the same chain of amino acids, it could still have a problem with post-translational "stuff." "Either sugars hanging off the molecule and folding in the wrong place and anything could cause immunogenicity." Immunogenicity, said Moore, is the "real reason" why innovator companies feel clinical trials should always be required. The FDA released a white paper stating that it has the ability to approve follow-on biologics without extensive clinical trials. However, the agency noted that some trials would be necessary for follow-on products to replace original products. GPhA has been pushing Congress to authorize an abbreviated approval pathway for follow-on biologics, citing excessive barriers.
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