There seems to be increasing amount of activity in the space of biosimilars and biogenerics (e.g. recent news on Hospira and the rights to generic filgrastim).

However, there are still some pretty major safety issues here with different production methods leading to molecular differences with a big impact on the drug safety profile.

It's clear there is a push from a government financial perspective to make this happen but just wondering where people think this will end up, and when?

Posted 16th October 2009, 15:26:03

Perhaps branded pharma will be forced to provide full disclosure of exact manufacturing process post patent expiry to allow generics companies to more easily produce comparable product?

Posted 27th October 2009, 17:47:48

cjb4 said
Perhaps branded pharma will be forced to provide full disclosure of exact manufacturing process post patent expiry to allow generics companies to more easily produce comparable product?

Yeah, good luck with that one!!!!

It's a brave generics company that pushes hard into this space right now. Even with the right regulations the manufacturing costs are pretty significant.

Posted 6th November 2009, 15:46:54

Not just generics companies.....Merck & Co., launched Merck Bioventures......

"While some big pharma companies are in the midst of buying up biotech firms, Merck decided that it could to the job itself, announcing on Tuesday that it will establish a biologics division called Merck BioVentures. The new biotech division will take advantage of the GlycoFi technology that Merck purchased in 2006 for $400 million. Glycoengineering allows scientists to produce proteins using yeast. The company is currently working on a follow-on version of Amgen’s anemia drug Epogen, and expects to have about five additional candidates in Phase III trials by 2012. To make sure everything goes smoothly, Merck plans to put $1.5 billion into the division by 2015"

Posted 10th November 2009, 16:20:36

I wonder how robust the yeast production method is for producing bioequivalent proteins (although the regulations are still settling on this one). The level of glycosylation is a big determinant of asorption, excretion and activity, in my understanding.

Different production systems can equal very different levels of glycosylation for biologics.

Not an expert here, more a layman's perspective - maybe someone who is can elaborate?