Senators: Get it right on biologics

As an entity devoted to promoting the businesses of the area and our members; the Chicagoland Chamber of Commerce is committed to making Illinois and the region the best place in America to work. There is a bill before Congress that would have the ability to catapult the Chicagoland area to the head of the biopharmaceutical class, which makes it critical that elected officials in Illinois get this right.

The issue at hand is medicines created through biology vs. chemical compounds. Medicines produced through chemical reactions are predictable and easily replicated such as a common aspirin. Medicines developed through advanced biotechnology are much more complex and therefore more difficult to replicate ("follow-on biologics").

We believe legislation establishing a regulatory approval pathway for follow-on biologics should require clinical trials to demonstrate that the follow-on product is safe and effective. Also, the FDA should have the authority to determine post-market surveillance requirements to monitor the safety of an approved follow-on biologic. Legislation regarding follow-on biologics should always keep in mind patient safety and incentives for innovation.

When the Senate returns in September, Senator Brown of Ohio is likely in introduce an amendment on the Senate floor that would slash the patent length of biologics reversing the vote of the Senate HELP committee and resulting in reduced innovation and riskier treatment for patients.

We strongly encourage Senator Durbin and Senator Burris to learn about the complexity of biosimilars and support legislation that would help ensure Illinois remains a world leader for innovation and research by preserving a 12-year patent length as currently called for by the Senate HELP committee.

Jerry Roper

President

Chicagoland Chamber of Commerce