Creating an avenue for regulatory approval will ensure biosimilars “are tested for safety while expanding access, lowering costs through expanded competition and providing incentives for biotech companies to continue innovating”, they write.

Though not well-known outside of doctors’ offices and hospitals, biologicals are helping patients across the country and throughout the world battle diseases such as cancer, multiple sclerosis and Alzheimer’s disease. Biologicals are biotech medicines made from living materials and are so complex that exact copies cannot be created with today’s science.

Key committees in US Congress recently agreed that it is vital to increase access to life-saving biologicals while ensuring that research and development in this burgeoning area of science can continue. Policymakers aim to achieve these twin goals by allowing the FDA to approve biosimilars, medicines sometimes erroneously called biogenerics.

The pathway to regulatory approval of biosimilars included in the US House and Senate healthcare reform bills will ensure that these medicines are tested for safety while expanding access, lowering costs through expanded competition and providing incentives for biotech companies to continue innovating.

The biosimilars provisions in the healthcare reform bills would improve the lives of the patients of today – and tomorrow. Patient advocates, doctors, labour unions, universities and governors, including US Governor Jack Markell, agree that the provisions must be included in the final healthcare bill.

“We encourage Senators Thomas Carper and Edward Kaufman and Congressman Mike Castle to join us in supporting a biosimilars pathway that protects patient safety and encourages continued innovation,” Mr Dayton and Mr Greenwood write.

References:
Bioscience advocates call for biosimilar support. BIO SmartBrief. 2009 Nov 3.

Del. delegation urged to back biosimilars action. DelawareOnline; Letters to the Editor. 2009 Nov 2.