About a week ago, Amgen rocked the biotech industry's proverbial boat with their announcement that they'd be entering the biosimilars market.
Multiple news outlets like Yahoo!, Forbes, and CNBC report that Amgen, starting in 2017, will be making six generic versions of blockbuster biologics:- Abbvie's Humira
- Janssen'sOLY 02/19/13 Remicade
- Roche's Avastin, Herceptin and Rituxan
- Eli Lilly's Erbitux
This comes as a surprise to many, because for years, Amgen has been saying that biologics really can't be copied.
You see, Amgen is facing patent expiration on it's blockbuster biologics. And unlike pharmaceutical companies, there really wasn't a need to be worried about patents expiring for biologics.
The U.S. Food and Drug Administration has long held that not only must the product meet quality specifications, but also the process that makes the drug must also rigorously meet process specifications.
Well, biologics are made by genetically-engineered microorganisms (cells) that conduct a symphony of biochemical reactions. You give these cells media; you control their environment (temperature, pH, dO2), and the cells do all the work making your protein out of the DNA.
Need to manage your cell culture data?
Need to manage your cell culture data?
Since the process specification includes these proprietary cells, it stands to reason that no one can produce the drug product if they don't have your cells. For this reason, biotechnology companies have not been as worried about patent expiration.
Up until this announcement, Amgen has been focusing on defending their superior position by indicating how difficult it is to manufacture biologics and how consumers ought not to trust biosimilars:
- Amgen's Challenges of Manufacturing Biologics (YouTube)
- Amgen's BuildingBiologics.com website saying that comparing biologics is like comparing snowflakes.
- Amgen's membership of SafeBiologics, a lobby against biosimilars
"It's really hard to manufacture biologics."
"When copies of our drugs are made, you can't be certain of their safety/efficacy."
But all of the sudden, our ancient weapons dealer who has been selling us his impenetrable shields has a new offering: his spears that can penetrate anything: 自相矛盾.
Amgen sees the writing on the wall. The FDA is being forced to develop a biosimilars approval pathway as a part of Patient Protection and Affordable Care Act (aka, "ObamaCare"). By law, the only way to do this is to renege on the "product and process" cGMP principle.
One of two things is going to happen:
Consistency issues aside, I think Amgen's gambit is genius.
But all of the sudden, our ancient weapons dealer who has been selling us his impenetrable shields has a new offering: his spears that can penetrate anything: 自相矛盾.
Amgen sees the writing on the wall. The FDA is being forced to develop a biosimilars approval pathway as a part of Patient Protection and Affordable Care Act (aka, "ObamaCare"). By law, the only way to do this is to renege on the "product and process" cGMP principle.
One of two things is going to happen:
- The FDA is going to allow biosimilars into the US markets.
- The FDA is NOT going to allow biosimilars into the US market.
Consistency issues aside, I think Amgen's gambit is genius.
5 comments:
Remicade is not an Abbott/Abbvie product, it was first produced by Centocor, which was acquired by J&J (now known as Janssen Biotech).
It's not a matter of "if" the FDA will approve biosimilars, it's just a matter of when.
Amgen is smart because they know that biologics aren't like small molecule drugs, hence, people will only trust the big name pharmaceutical companies when it comes to quality (at least initially). Also, the originator molecule is likely to hold onto some market share, unlike the small molecule drugs.
So what Amgen is doing is say "Hey, someone else is going to come and take a bite out of our product, so let's take a bite out of everyone else."
They also have the know how to make it happen.
"Since the process specification includes these proprietary cells, it stands to reason that no one can produce the drug product if they don't have your cells."
This statement is just plain wrong.
You might want to do some homework before you post these nuggets of wisdom.
I'm explaining why biologics innovators WEREN'T worried about biosimilars in the past (2004 to 2009ish).
Clearly, they ARE worried about biosimilars today (2010 to 2013).
What we know today is that drugs can be produced even if you don't have their cells.
If you're asserting that the actual cells are NOT a part of the process specification, you're going to have to provide some citations.
The FDA historically made innovators go back to the clinic if the innovator changed out the their original cell line for version 2.0 processes.
Thanks for the comment. I was mindlessly quoting Y! who got that Abbvie Remicade association incorrect. You're absolutely right on the Remicade genealogy.
Thanks for your insights.
Wikipedia seems to agree with zymergi.
"Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product."
http://en.m.wikipedia.org/wiki/Biosimilar
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