Biotechnology Organizations Comment on New Follow-on Biologics Proposal
The Biotechnology Industry Organization (BIO) and the Massachusetts Biotechnology Council (MBC) reacted to the Biologics Price Competition and Innovation Act of 2007 that was recently approved by the Senate Health, Education, Labor and Pensions Committee this week.
The legislation, cosponsored by Sens. Edward Kennedy (D-Mass.), Mike Enzi (R-Wyo.), Hillary Rodham Clinton (D-N.Y.) and Orrin Hatch (R-Utah), is intended to create a pathway for the approval of follow-on biologics. Biologics are used to treat diseases such as cancer, HIV/AIDS and Parkinson’s disease along with a host of rare diseases. Follow-on biologic products will not be copies of, but rather will be similar to, life-saving, pioneering biologics.
The organizations said the legislation takes an important step toward establishing a pathway for approval of follow-on biologics, ensuring access for patients to lifesaving biologics and protecting continued biomedical innovation.
However, the organizations were concerned that the bill also insufficiently protects patient safety and the patient-doctor relationship.
BIO and MBC also said that the proposal would allow follow-on products to be substituted for the original innovator product without the intervention of the health care professional who prescribes the biologic product, taking medical decision-making for individual patients out of the hands of doctors.