Washington, D.C. (April 10, 2014) – The Biotechnology Industry Organization (BIO) and the Delaware BioScience Association (Delaware Bio) commend the Delaware State Senate for passing legislation yesterday designed to create a pathway for the substitution of interchangeable biologic medicines.
The Delaware State Senate passed Senate Substitute 1 for Senate Bill 118 by a unanimous vote. The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and Delaware Bio support passage of this bill as it moves for consideration by the Delaware House of Representatives.
“Senate Bill 118 enjoys the support of a broad coalition of biologic and biosimilar manufacturers, along with industry, physician and patient groups,” said Jim Greenwood, BIO’s President and Chief Executive Officer. “This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record. This legislation represents a significant step forward, ensures transparency and communication between patients and their treatment teams and is fully consistent with the BIO principles.”
While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. Senate Bill 118 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies. BIO will continue to advocate for full transparency in the substitution process, as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.
“This legislation will benefit Delawareans when interchangeable biologics are approved by the FDA,” said Greenwood. “When they become available, these therapies will be safe, effective, and similar to innovator biologics. Furthermore, they will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
The FDA is currently developing a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.
As the Delaware General Assembly continues to address issues related to biologic substitution, BIO and Delaware Bio encourage policy makers to continue to put patients first.
About Delaware BioScience Association
Delaware Bio is a non-profit trade association that serves its members and the State of Delaware by collaborating with other local businesses and organizations to advance the growth of the bioscience industry in Delaware and the region (www.delawarebio.org).