merck bio similar landscape

8/3/2019 Merck Bio Similar Landscape

1/4

Biotech: Merck Day Slides And Notes RE: Biosimilars by Biotech Due Diligence | This entry was

posted on Tuesday, January 17th, 2012 and filed under Stock Market Comments Off

See below for some snippets and slides from Merck R&D day about their biosimilars programs

(saved before more recent headlines about new Enbrel patent, AMGN-WPI, and BAX-MNTAcollaborations). Perhaps the slide and commentary collection will be useful to you.

Now Europe first introduced a biosimilar pathway in 2005 for three molecules including humangrowth hormone, erythropoietin and the colony stimulating factors, granulocyte colony stimulatingfactors.These three were among the earliestbiotech products and theyre the simplest in size andstructure. In the EU the approval packages using this new pathway required analytical, preclinical,clinical and immunogenicity studies and draft guidelines for the regulatory approval of theimportant monoclonal antibody biosimilars in Europe are currently in discussion and were waitingfor those guidelines to be formally approved and issued. In the United States, the biologics pricecompetition and innovation act of 2010 created a legal pathway for approval of biosimilars, but itdid not detail the regulatory requirements for the development and licensure steps. So were alsowaiting for these guidelines to be issued, hopefully before the end of this yearNow, while waitingfor this forma guidance, we continue to discuss our specific programs with the regulators. Wevehad numerous meetings to date, weve gotten some feedback from them, we extrapolate from thoselearnings to all of our development programs. So we desperately need the overview, both from theUS and Europe to understand what the full requirements for this business are going to beWevecommitted over 200 people in R&D to the development of the Merck bioventures portfolio.Weveestablished partnerships to obtain critical molecules, such as the deal already mentioned withHanwha to obtain a biosimilar version of Enbrel. Weve invested over $200 million in building ourinternal manufacturing infrastructure for biosimilar and novel programs.Internally we have six facilities that were making our biological products in. And then, recently, weconcluded a partnership with a MedImmune with MedImmune for their manufacturing capacity

in their brand new facility in Frederick Maryland. Finally, for clinical development weve partneredwith Parexel in an exclusive biosimilars deal. Theyre working to provide uswith access to approximately 500 worldwide clinical sites to do our biosimilar clinical work.

Now, because Enbrel is one of the earliest freedom to operate dates for Merck we believe its going

to be the lynchpin in this new business. This portfolio also allows us to continually prioritize our

investments behind the best opportunities. Using the strategies outlined earlier by Peter, well

select from these molecules that have the highest potential relative to the development

costs, highest probability of technical success and those molecules for which we have the highest

probability of being a first mover.

Now, while we wont wait for the formal global guidance on biosimilars to be issued, before

moving to late stage development, we do need formal clarity around a number of crucial issues. For

example, the apparent requirement for using only locally sourced comparator material for our

Phase III studies that are intended for global registration.Thats a challenge. In this context

of regulatory ambiguity, we dont expect to have five molecules in Phase III by the end of 2012.

Instead, the timing of Phase III starts will be determined by the regulatory guidance and the

ongoing prioritization of our portfolio.That said, Ill remind you that its the freedom to operate


2/4

dates that are most critical in the timing of the launch of our products.

Finally, biosimilar the market opportunity for biosimilars is large, with important patent expiry

starting in the middle of this decade. Merck BioVentures has made progress in developing a

portfolio of biosimilar targets, securing partnerships to enhance the portfolio and capabilities while

actively engaging with regulators as they develop the final pathways. All of this is with agoal of pursuing the highest potential molecules and making them ready to enter the market when

we have the freedom to operate.


3/4


4/4

merck bio similar landscape

Documents