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.
Will Biosimilars Drive Process Innovation?.
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.
Feel the 'Aha' comment of Tom is becoming much more reality. As Ron said, price becomes the key for commercial success of biosimilars. Also, the number of competitors have grown hence early bird gets the chunk of pie, possibly exclusivity. Moreover, for interchangeability you need very less differences between biosimilar and innovator to build the confidence of regulator. Hence the development path has to be as short and optimum as possible. With highly innovative and incisive development at early stage (before Ph1) and showing absolute similarity can get concessions from regulators (like FDA) for shorter development time, hence faster to market and can be a winning formula!
Posted by: Shrivathsa | 09/03/2012 at 08:40 PM
I think you're right that there will be a barbell pattern here. Either invest as little as possible in the process development and get to market first, or take the approach that Momenta Pharma MNTA is, invest heavily in characterization and process development in order to so precisely copy the reference drug that they can achieve interchangeable status
Posted by: BioDueDiligence | 08/29/2012 at 08:16 PM