Wednesday, December 14, 2016

Possible Problems with Piosimilars

Sorry, I couldn’t resist the temptation. I’d like to talk about possible problems with biosimilars. I’ve just read the article on Medscape by Dr. Jonathan Kaye: “The March of the Biosimilars Continues”. In the U.S. the etanercept biosimilar Erelzi™, the adalimumab biosimilar Amjevita™, and the infliximab biosimilar Inflectra® are approved by the FDA. In Europe we already have more biosimilars: the infliximab biosimilars Remsima®, Inflectra®, and Flixabi®, whereof Remsima® and Inflectra® are bioidenticals. And we have the etanercept biosimilar Benepali®.

One problem will be changing from originator to one and even to a second biosimilar to fulfill biosimilar quota. I think this is a bad idea both for medical and legal reasons.

Another problem arises out of the number of originator biologics (already) and biosimilars. Rituximab biosimilars will follow soon. Have look at the IMS Infographic, there are 23 biosimilars are almost ready to be filed for approval. Rheumatologists will spend quite a lot of time with their patients and assistants or nurses to sort out, which product to use and how to avoid confusing one with the other.

But maybe I see more problems than solutions. And maybe I’d be better off with Padre Pio: “Pray, hope, and don't worry. Worry is useless. ...”

Bioidenticals - Biosimilars - Biologics – Biomimics -

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