Pharmacy News Article

WASHINGTON-Biotech drugmaker Amylin Pharmaceuticals Inc. spent $350,000 lobbying the federal government in the first quarter, according to a recent disclosure form.

San Diego-based Amylin lobbied on legislation that would allow the Food and Drug Administration to approve copies of biotech drugs, reimbursement issues, drug safety and physician payment disclosures.

A key issue for the entire biotech industry is the future process for making biosimilars, or copies of biotech drugs akin to what generic drugs are to chemical-based treatments. The FDA regulates the approval of generic drugs made from chemical compounds, but does not have a system in place for similar versions of biotech drugs, which are developed using more complicated, living cells.

Amylin makes the diabetes drug Byetta in partnership with Eli Lilly & Co. and Alkermes Inc.

The generic drug industry is supporting bills that call for about 5 years of market exclusivity for biotech drugs before copies can be introduced in the market. The biotech industry has been supporting proposals for up to 14 years of sales free from competing copies on the market. Both sides are at odds over how much time it takes for companies to recoup development costs and make a profit.

Currently, companies making biotech drugs face no competition similar to that of its traditional pharmaceutical peers after products lose patent protection.

Besides Congress, Amylin lobbied the FDA and Department of Health and Human Services in the January-March period, according to the form filed April 17 with the House clerk's office.