BIO Encourages Transparency with Support of Biologic Interchangeability Bill

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BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.


The Biotechnology Industry Organization (BIO) and the Colorado BioScience Association (CBSA) want to make it possible for patients to access interchangeable biologic medicines, they just need one signature to help get the legislation passed. CBSA, who just recently passed Senate Bill 71 (also passed by Senate), along with BIO are encouraging Colorado’s Governor Hickenlooper to sign the bill to keep biologic interchangeability transparent for patients.

“Senate Bill 71 enjoys the support of physicians across the country, patient groups, and both innovator 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,” said Jim Greenwood, BIO’s president and CEO, in a press release.

FDA has the final say in biologic interchangeability approval, however, state legislation decides whether or not a product may be substituted in place of a doctor’s prescription and if pharmacists must inform patients and doctors of the interchangeability. As is written in the bill, the pharmacist must inform the purchaser if he or she is administering an interchangeable biological product, however, the pharmacist is not permitted to substitute an interchangeable biological product unless it costs the purchaser less than the drug or biological product prescribed. If the prescribed biological product is not in stock, and the interchangeable biological product is priced higher, the pharmacist may give the higher-priced biologic after informing the purchaser.


“This legislation will benefit Coloradoans when the first interchangeable biologics are approved by the FDA. 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,” said April Giles, president and CEO of CBSA, in a press release.

The first biosimilar was approved in the US by FDA in the first week of March 2015, and stated that it believes we will see interchangeable biosimilar product approvals starting this year. Urging legislators to pass this bill will help to keep transparency a part of the patient care process when giving interchangeable biologic medicines.

Source: BIO