CHI VP provides testimony on patient, physician notification of biosimilar substitution

April 9, 2013 10:20 AM

California Healthcare Institute (CHI) Vice President of State Government Affairs Eve Bukowski yesterday provided testimony before the Senate Business, Professions and Economic Development Committee on the importance of notifying physicians when a patient’s biologic prescription has been substituted with a biosimilar drug.

Bukowski, who was diagnosed with stage-four colon cancer, spoke from personal experience and urged the committee to consider patients in the process.

“All of us with diseases treated with biologic medicines understand the instability of our health and the risks of side effects associated with our treatments. It’s a risk we are willing to take for the benefits we receive,” Bukowski said. “Informing the physician of a substitution is not only consistent with current pharmacist-physician interaction, it’s a simple precautionary step.”

Unlike their pharmaceutical counterparts, biotech drugs are made from living organisms and derive from more complex manufacturing processes involving sensitive fermentation and purification. Biosimilars are products “highly similar to” or “interchangeable” with a U.S. Food and Drug Administration-licensed biological product.

New legislation known as SB 598 and authored by Sen. Jerry Hill (D-San Mateo) would regulate the dispensing of biosimilars. It would require patient and physician notification of biosimilar substitution and that the full name and manufacturer be indicated on the medicine’s label.

“SB 598 recognizes that because biologic medicines are not the same as chemically-based generic medicines they need their own set of rules,” Bukowski said.

The committee also heard from Geoffrey Eich, executive director of regulatory affairs at Amgen.

California is known as the “birthplace of biotechnology,” where life-saving biologics such as Avastin and Epogen were developed. The state’s biopharmaceutical industry employs 42,886 people, more than any other state in the nation. The industry is responsible for producing innovative products for treating heart disease, cancer, diabetes, multiple sclerosis and Alzheimer’s disease that serve to benefit millions of patients in the United States and around the world.

 

Source: CHI press release

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!