IBJNews

Biosimilars bill passes House, heads to governor

Back to TopCommentsE-mailPrintBookmark and Share

Pharmacists would be able to substitute an interchangeable biosimilar drug for a prescribed name-brand product under a bill passed by the Indiana House of Representatives on Tuesday.

The bill now moves to the governor’s office for consideration.

The legislation, authored by Sen. Brandt Hershman, R-Buck Creek, creates a series of steps to ensure the safety of automatic substitution of biosimilar medications.

“While the science behind these drugs is very complex, this issue is very simple from policy standpoint,” said Rep. Ed Clere, the House sponsor for the bill. “The bill ensures communication between providers, patients, and pharmacists, during the dispensing process.”

Senate Bill 262 includes the five principles supported by BIO, the Biotechnology Industry Organization:

- The FDA must deem a drug interchangeable before it can be substituted.

- The physician must allow for substitution.

- The pharmacist must notify the patient of the substitution.

- The pharmacist must notify the doctor of the substitution.

- Both the pharmacist and the doctor must keep a record of the substitution.

The bill is similar to legislation that was passed by the House during last year’s legislative session but was killed by the Senate.

“The Senate incorporated several changes this year to preserve the five principles, while also addressing concerns that have resulted in some of the folks who opposed the legislation last year, now switching and supporting the legislation this year,” Clere said while addressing the House. “So we have an even better bill than what most of you supported last year.”
 

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. So, Pence wants the federal government to ignore the 2008 law that allows children from these countries to argue for asylum in front of a judge. How did this guy become governor? And how is that we'll soon be subjected to repeatedly seeing him on TV being taken seriously as a presidential candidate? Am I in Bizzaro-U.S.A.?

  2. "And the most rigorous studies of one-year preschool programs have shown short-term benefits that fade out in a few years or no benefits at all." So we are going down a path that seems to have proven not to work very well. Right intention, wrong approach?

  3. Well for Dunkin Donuts it might say that even a highly popular outlet can't make a poorly sited location work. That little strip has seen near constant churn for years.

  4. Years ago, the Pharmaceutical and Medical Device companies shifted their research investment away from Medical Institutions to focus more on private research centers, primarily because of medical institution inefficiencies in initiating clinical studies and their inability/commitment to enroll the needed number of patients in these studies. The protracted timelines of the medical institutions were prompting significant delays in the availability of new drug and medical device entities for patients and relatedly, higher R and D expenditures to the commercial industry because of these delays. While the above stated IU Health "ratio is about $2.50 in federal funding for every $1 in industry funding", the available funding is REVERSED as commercial R and D (primarily Phase I-IV clinical work)runs $2.50 to $1 for available federal funding ($76.8B to $30.9B in 2011). The above article significatly understated the available R and D funding from industry......see the Pharma and Medical Device industry websites. Clearly, if medical institutions like IU Health wish to attract more commercial studies, they will need to become more competitive with private clinical sites in their ability to be more efficient and in their commitment to meet study enrollment goals on time. Lastly, to the reference to the above Washington Post article headlined “As drug industry’s influence over research grows, so does the potential for bias", lacks some credibility as both FDA and Institutional Institutional Review Boards must approve the high proportion of these studies before studies are started. This means that both study safety and science must be approved by both entities.

  5. ChIeF and all the other critics – better is better no matter what. Get over it; they are doing better despite you ?

ADVERTISEMENT