The Biotechnology Industry Organization (BIO) and the Delaware BioScience Association (Delaware Bio) are urging Delaware Gov. Jack Markell to sign legislation that would establish a pathway for the substitution of interchangeable biologic drugs.


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BIO calls on Delaware governor to OK biosimilars bill

May 15th, 2014

WASHINGTON – The Biotechnology Industry Organization (BIO) and the Delaware BioScience Association (Delaware Bio) are urging Delaware Gov. Jack Markell to sign legislation that would establish a pathway for the substitution of interchangeable biologic drugs.

BIO said the Delaware House of Representatives unanimously passed an amended version of Senate Substitute 1 for Senate Bill 118 late Tuesday, which sent the bill back to the Senate, where it received a unanimous approval Wednesday evening. A similar version of the bill was originally passed by the Senate, also by unanimous vote, last month.

The legislation would authorize pharmacists to substitute Food and Drug Administration-approved, interchangeable biosimilars for prescribed biological reference drugs in accordance with certain safeguards. To substitute a biosimilar, pharmacists must provide notices, record information on the label and dispensation record, and maintain a three-year record of the substitutions. In addition, the bill also provides liability protections for pharmacists who substitute biosimilars.

"Senate Substitute 1 for Senate Bill 118 enjoys the support of physicians across the country, patient groups, and both biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record," BIO president and chief executive officer Jim Greenwood said in a statement. "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."

BIO noted that although the FDA oversees approval of biologics and designation of interchangeability, policies on whether a product can be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. The group said that Senate Substitute 1 for Senate Bill 118 aims to preserve patient access to accurate prescription information, upholds incentives for innovation and promotes a competitive market for biologics.

"This legislation will benefit Delawareans when interchangeable biologics are approved by the FDA," added 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."

Currently, the FDA is developing a pathway for the development and approval of safe and effective interchangeable biologics in the United States. But BIO stressed that there's still a key role for states to play in ensuring that substitution practices remain transparent and doctors remain engaged in the process.

"Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely," Greenwood noted. "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."

BIO added that patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances, and communicating with patients and physicians gives everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.

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