Thursday, January 21, 2016

Why the Regulation of Biosimilars is Integral to Their Success

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As far as many patients are concerned, biosimilars are a confusing topic. With more pharma companies like Amgen working on biosimilars to popular name-brand drugs, this is an incredibly timely issue.

When you add in that some biosimilars 'interchangeables' - specifically, comparable with their name-brand counterparts - that can increase the confusion.

Biosimilars bring tons of new promise for many chronic or terminal illnesses:
The sales decline has companies like Roche working rapidly to develop new drugs that can replace the lost sales. Roche, in particular, is working on a series of new cancer drugs focused on areas like melanoma, lung cancer, and breast cancer that are expected to launch over the next three years in hopes of closing the sales gap created by new biosimilar rivals.
Perhaps this means that the 'moonshot' to cure cancer or the future of patient engagement will be accelerated as well.

There are many things to consider, like the differences between biologics and their biosimilars, the approval process, and patient safety concerns. One recent concern has been the naming of biosimilars. Thankfully, there is a proposed rule regarding the naming of biosimilars from the FDA.

One other sticking point has been patient and physician notification. A fear that many of us on biologics have is receiving a substitute of our medications without knowledge. If our illnesses worsen as a result of the subtle differences and we can't control the disease any longer on that type of drug, this uproots our entire lives from work to caring for our families to our mental health.

Living with a rare autoimmune/autoinflammatory disorder, I've failed seven medications in five years. The last thing that I want to do now that I'm stable is to have my medication - my livelihood - disrupted in such a way. This is especially true know how situations between generics and name-brand medication can play out. Biologics are much more intricate, much more intense. They often can have worse side effects than non-biologics.

For patients to truly buy-in to biosimilars, we're going to have to be courted - to have their safety proven to us beyond a doubt and to be given a choice regarding going on biosimilars. Hopefully insurance companies are listening.


Amgen: Biosimilars versus Generics
Biosimilars & Patient Notification

Creaky Joints: Biologics and Biosimilars
FDA: Information for Consumers (Biosimilars)
Fortune: Biosimilars Are Coming After Big Pharma's Bottom Line
Generic Pharmaceutical Association: Biosimilars
Healthy Biologics: What Are Biologics?
International Business Times; What Are Biosimilars? Zarxio, First Drug Of Its Kind Approved In US
Not Standing Still's Disease: Terminology Tuesday: generic vs biosimilar vs brand name 
The Truth About Generic Vs. Brand-Name Medications
Unique Names for Biosimilars

About the author:

Kirsten Schultz is a health activist and blogger. You can read more about her life living with multiple chronic illnesses on her blog, on Creaky Joints, or follow her on Twitter.  

She will also be joining us this year at ePharma as an official guest blogger sharing insights from the event. 
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