Interesting hypothesis discussed in the Bioprocess Blog. The author opines that biosimilars manufacturers will need to become experts in process and analytical development -- and in fact will drive the state-of-the-art.
The reason cited is that these manufacturers will need to produce molecules that are "highly similar" to a reference product and essentially will need to have a process that will deliver this prior to Phase I trials -- a standard not as dramatically imposed on innovative product producers.
The key thought being "Without the ability to proceed rapidly through clinical development using a robust commercial manufacturing process, much of the economic and speed advantage of developing a biosimilar product will be lost."
Therefore, it is argued these manufacturers will need to come up with innovative technologies to speed process and analytical development to deliver reliable scale up and cost-effective manufacturing.
I'm not so sure. Biosimilar producers can work with serviceable processes as long as they can get to market and produce. They may not be optimized at introduction -- but if they are first to market -- I think they'll still make money. And, they can then work on improvements to their processes after the fact just like innovators regularly do now.
However, being a process and analytical innovator will confer advantage and it would be a good business model to pursue to differentiate oneself competitively in the biosimilar arena. It's somewhat counterintuitive to think about biosmilars producers being innovators -- but this idea certainly has its merit if they can pull it off.
I don't think it is unreasonable for someone to try. I see some evidence now that some biosimilar producers are trying their "own" production systems to make their "similar product" and aren't necessarily trying to mimic what the "best guess" innovator process is -- if that doesn't really fit their experience and expertise. Of course, many are also trying to mimic the "best guess" process too under the theory that it is most likely to match the innovator molecule. We'll see which works best.
Posted by Bruce Lehr Aug 29th 2012.