Pennsylvania has taken a step closer to adopting legislation which would authorize pharmacists to be able to substitute FDA-approved biosimilars for their reference biologicals, but with certain restrictions.
On 13 November 2013, the Pennsylvanian Senate Public Health and Welfare Committee voted overwhelmingly in favour of legislation known as SB 405 forbidding a pharmacist from substituting a biosimilar for a brand-name biological if a physician prohibits the substitution. The bill also requires pharmacists to notify the doctor (within 72 hours) and retain a record of the substitution.
On 12 October 2013, California Governor Jerry Brown vetoed similar legislation in California, known as SB 598, a bill that some believed would have impeded access to biosimilars [1]. Governor Brown rejected the legislation on the grounds that the bill was premature given the fact that the US Food and Drug Administration (FDA) has yet to release finalized guidance on biosimilars.
The Pennsylvania bill was passed after adding some minor amendments. One of the amendments approved by the committee reduced the length of time records on biosimilars substitutions must be retained from five to two years.
Similar bills are, or have been, contemplated in several other US states. Supporters of such bills on biosimilars substitution argue that they do not prohibit substitution, but rather protect patients. Biotech giant Amgen has stated that ‘substitution rules that strengthen communication between physician, pharmacist and patient will help accelerate the successful implementation of the US biosimilars pathway’ [2]. However, advocates for biosimilars substitution, such as the Generic Pharmaceutical Association (GPhA), say that procedures outlined in the proposed bills ‘would create red tape between patients and affordable medicines’ [3].
The Pennsylvania bill, which passed 11-0, will now go to the state Senate for a vote.
Related articles
US state biosimilar substitution bill becomes law
Biosimilars bills move on in two US states
Source: www.gabionline.net
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