Health Law partner Lisa J. Acevedo of Foley & Lardner LLP, a leading intellectual property law firm, spoke at a luncheon seminar during Bio Japan 2004.
On September 14, the Federal Drug Administration (FDA) held a public workshop to examine guidance for the approval of generic biologics. However, the FDA put the draft proposal on hold pending public input due to a sharp division of opinion between the manufacturers of drugs and biologics.
The drug manufacturers contend that "biologics are created by a special process, and they are different from low-molecular-weight drugs, which can be truly duplicated by structure," said Acevedo.
On the other hand, companies aiming at creating a biologic have an attitude that "it is possible to show the resemblance at least by using sophisticated analytical tools," said Acevedo. The two sides could not resolve their differences, and the FDA was unable to come to a conclusion to complete the guidance.
There is a move to establish an approval process for generic biologics by legislation. However, it is highly possible that data on prior biologics will be referenced in the approval process, and there are several issues related to the protection of intellectual property rights.
Acevedo stated that Medicare reform legislation, which was passed last year by the Bush Administration, would trigger completion of the FDA guidance for the approval of generic biologics. The Medicare reform legislation includes the provision that prescription drugs should be covered for people over 65 years old, and will go into effect in 2006.
Biologics will still be expensive without a system that releases them after the term of patent protection. There is no other choice but to introduce a structure for the approval of generic biologics, since the national burden of medical costs would balloon astronomically due to the enactment of Medicare reform legislation.
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