Here's an article at Genetic Engineering & Biotechnology News on the top 10 innovator drugs competitors are trying to copy.
It's no wonder why Amgen needs to start playing offense. And it's no wonder why they need to start now when the regulatory pathway for biosimilars is still a work-in-progress (WIP).
I'd like to see these companies get more lean and compete on manufacturing agility as well as efficiency.
Processes need to be better specified... the operating space ought to be better characterized (QbD).
Once the technology is transferred to large-scale, there ought to be a program to continuously improve these processes to eliminate variability and increase process understanding (PAT).
All of this manufacturing sciences and technology is already happening, but I have yet to see companies trot it out as a core competency.
It's not sexy, but in a world where your top-line revenues are in decline, focusing on bottom-line numbers is one of many viable paths.
- Amgen's Aranesp
- Amgen's Enbrel
- Amgen's Epogen/Procrit
- Pfizer's Genotropin
- Roche's Herceptin
- AbbVie's Humira
- Amgen's Neulasta
- Amgen's Neupogen
- Janssen's Remicade
- Roche's Rituxan
This list appears to be alphabetical (by the drug's trade name). As you can see, 5 of the top 10 biologics that are marching inexorably towards patent expiration belong to Amgen.
It's no wonder why Amgen needs to start playing offense. And it's no wonder why they need to start now when the regulatory pathway for biosimilars is still a work-in-progress (WIP).I'd like to see these companies get more lean and compete on manufacturing agility as well as efficiency.
Processes need to be better specified... the operating space ought to be better characterized (QbD).
Once the technology is transferred to large-scale, there ought to be a program to continuously improve these processes to eliminate variability and increase process understanding (PAT).
All of this manufacturing sciences and technology is already happening, but I have yet to see companies trot it out as a core competency.
It's not sexy, but in a world where your top-line revenues are in decline, focusing on bottom-line numbers is one of many viable paths.
1 comment:
Biogen Idec seems pretty confident in its abilities.
http://www.biogenidec.com/research_manufacturing.aspx?ID=5779
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