Lionhearted, I mostly agree with what you are saying, but do see a couple of matters differently.
Firstly, I consider use of the term “follow-on biologic” to be too broad, as there are three distinctly different types of follow-on biologics. According to Thomson Reuters
Follow-on biologics that are proven to be “highly similar” to a reference product and meet the relevant regulatory requirements of safety, purity, and potency are considered biosimilar to the reference product. If the marketer of a biosimilar product can prove that there is no increase in risk or diminished efficacy when switching between the reference drug and the follow-on product (rather than when using only the reference product), the biosimilar product will be deemed interchangeable. Follow-on biologic products that receive approval via a biologics licensing application (BLA) should not be called a biosimilar or interchangeable. Approved products that have improved attributes of the original product are considered biobetters. ^
PYC has the potential, as I understand it, to add value in biobetter development, in other words, taking an existing biologic and making it, as you say, “more effective by better targeting, delivery, lower dosage etc.’
Following on from the above point, I don’t agree with the statement
“The financial implications to big pharma are a 10 fold reduction in cost/time getting the drug to the market because of prior clearances of the previously accepted drugs.”
This may be the case for biosimilars, but not for biobetters.
Biosimilars are approved under the 351(k) pathway which permits approval based on solid evidence of structural similarity and small confirmatory clinical trials. This makes biosimilars faster and cheaper to market than new active agents. Estimates I have found for the time and cost to get a biosimilars to market in the US are 6-9 years and $100 -$150 million.
However, a biobetter can’t use the 351(k) regulatory pathway. It requires approval under a BLA. Therefore, development of biobetters doesn't come with huge time or cost savings.
However, biobetters do have their own advantages, as seen in the list below
- A biobetter does not have to wait until a patent expires on the originator product before the product can be launched in the market.
- Greater potential to avoid infringing patents or at least lower litigation costs since it is not claiming similarity to the originator product.
- Biobetters have an advantage over biosimilars as they constitute an improvement over the originator and any biosimilar competitors, and should therefore be patentable.
- A biobetter can command a price premium, as it has a clinical advantage over the originator product. Biobetters should be less cost sensitive when compared to a biosimilar because they are in essence a new compound.
- As a new chemical entity a biobetter will be given data exclusivity for 12 years in the US and 8 years in the EU. *
I’d argue that it’s those advantages that might attract Big Pharma to exploiting PYC’s Phylomer library for the development of biobetters, especially pharma with highly lucrative biologics which are facing patent expiration.
^
http://thomsonreuters.com/content/d...fe-sciences/white-paper/newport-biologics.pdf
http://www.fda.gov/drugs/developmen...ations/therapeuticbiologicapplications/biosim
https://www.imshealth.com/files/web/IMSH Institute/Healthcare Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf
http://www.outsourcedpharma.com/doc/what-s-next-for-the-biosimilars-market-0001
*
http://prahs.com/download/whitepapers/The_Value_of_Biobetters.pdf
(20min delay)