Abbvie's Humira

Janssen's OLY 02/19/13 Remicade

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.









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."





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.





by Oliver Yu

The FDA is going to allow biosimilars into the US markets. The FDA is NOT going to allow biosimilars into the US market. Someone at Amgen put their brain on and decided no matter what happens, they were going to win.



Consistency issues aside, I think Amgen's gambit is genius. "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:Someone at Amgen put their brain on and decided no matter what happens, they were going to win.Consistency issues aside, I think Amgen's gambit is genius.

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: