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HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

056 - Entering the era of biosimilars!

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

Sean P. Kane, PharmD, BCPS

Health & Fitness, Medications, Rosalindfranklin, Rfums, Pharmacy, Pharmd, Pharmacist, Medicine, Drugs

5644 Ratings

🗓️ 7 February 2017

⏱️ 32 minutes

🧾️ Download transcript

Summary

In this episode, we discuss the new FDA categorizations of biosimilars, the legal implications of biologic/biosimilar prescriptions, and the new "follow-on" approval pathway of Basaglar, a new insulin glargine U-100 product.

Transcript

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0:00.0

Welcome to Helix Talk, an educational podcast for healthcare students and providers covering real-life clinical pearls, professional pharmacy topics, and drug therapy discussions.

0:11.0

This podcast is provided by pharmacists and faculty members at Rosal Franklin University College of Pharmacy.

0:17.0

This podcast contains general information for educational purposes only. This is not professional

0:22.5

advice and should not be used in lieu of obtaining advice from a qualified health care provider.

0:27.2

And now on to the show.

0:31.0

Welcome to Helix Talk, episode 56. I'm your co-host, Dr. Kane. And I'm Dr. Patel. And today, actually, we're going to talk about a very interesting topic of biosimilars.

0:42.2

We're going to call it entering the era of biosimilars.

0:45.5

So before we get into biosimilars, I think we really have to talk about, you know,

0:48.7

what are some of the definitions that surround the topic of a biosimilar?

0:52.3

So biologics is probably the first thing that we have to talk about.

0:55.9

Right.

0:56.2

And those were the agents that came out in the market first.

0:59.5

And biosimilars, as the name sounds, they're similar to these biologic agents.

1:04.4

So, yes, I totally agree we need to understand what the biologics are.

1:08.7

And these biologic drugs or agents are basically, as the name

1:12.3

suggests, are created biologically. They're very complex molecules, and so per batch, there could be

1:18.6

variation in the molecule size or shape in itself. When you describe it as biologically produced or

1:24.8

created, we're talking like bacteria with recombinant DNA technology where the bacteria themselves

1:31.3

or some organism is producing these complex, typically protein-oriented molecules.

1:36.7

So it's not like some kind of test tube is creating a chemical reaction.

1:40.0

It's literally a DNA molecule that's given to a bacteria to make the thing that we're wanting,

1:45.9

which we call a biologic.

...

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