Wednesday, February 6, 2013

Drug Delivery Partnerships 2013: Biosimilar Drug Development

Drug Delivery Partnerships 2013 kicked off today in sunny San Diego. Over the next three days, we'll be capturing many of the session for The Drug Delivery Blog so you can refresh on the learnings of the conference or virtually attend through the web. Our first recap comes from the workshop Two Steps Forward, One Step Back: Biosimilar Drug Delivery Development.

Our first speaker of the afternoon was Thomas Nikolai, Director, Biologics and Parenterals at Hospira.  He started off by looking at the different types of devices that were available for biologic and biosimilar delivery.  Where do devices fit in with biologics?  The two main medications that are dependent on biologic drug delivery are anti-TNF antibodies and cancer antibodies.  They have switched positions between #1 and #2 in terms of sales.

The biosimilars space is full of promise with a new headline from a company full of potential every day.  But in reality, there are a large number of companies are competing in a marathon to find success. Biosimilars are developed to be similar in terms of function, efficacy and safety in terms of the originator product. In the European market, the structure for approval is established. Europe has developed specific guidelines in different therapeutic classes.

One company tapping into the biosimilars market is Hospira.  They have one of the larger biosimilars pipelines in the world. They have a global biologic R&D manufacturing network with a headquarters in Chicago, and R&D arms in Europe, India, Australia and a partner in South Korea.

It's important take a few things into consideration for biosimilar combo products.  Nikolai points out specifically these governing principles: high, uncompromising level of science; cost-effective R&D and manufacturing; Platform where possible; evaluating opportunity costs, and planning for success. These products will be sold at a discount means that the price model is not close regular generics. Biosimilars companies need to be able to realize the opportunity to have faster development cycles with efficient processes.

The development cycle for biosimilars  is shorter because they do not have to go through Phase II studies and less time is spent in Phase III studies. Planning for success of a biosimilar means things should be done earlier and typical decision points that are used for originators aren't applicable. There is regulatory flexibility, but there are constraints that if you do move, there must be proof that you haven’t altered the major factors of the product.

FDA wants companies with biosimilars to show comprehensive analytical data that proves the biosimilars is comparable. From there they can determine what needs to be done in terms of clinical trials.

Our second presentation of hte day was Biosimilars: The Payers Prospective from Steven Miller, CMO of Express Scripps.  Currently in the United States as payors, we’re spending $2.7 trillion on healthcare on an annual basis. This is twice as much as any other western country.  Even with the exorbitant amount, Americans are seeing the best quality of care they could..

 Biologic spending reached $160 billion in 2011. It’s the fastest growing segment in Pharmaceuticals. The US will be a single payors them by 2017 as they’ll have control of 50% of medical payments. The single biggest innovation is how to control costs and keep the margins with the competitive pressure of costs. After 2017 large employers can move to the exchange.

 Where is the $2.7 trillion spent? Hospitals, pharmaceuticals, doctors, nursing homes, etc. How does a company create a valuable product that can join the mix? A good value proposition is needed. At least 70% of all Pharmaceutical spending is for traditional oral pills, 30% are for specialty drugs, will move as biologics continue to grow in use. That's not all that's growing in the pipeline.  There currently are 5400 drugs in human testing, 1600 for orphan drug testing. Specialty products are getting approved faster that traditional and has been since 2010. Two obesity drugs were approved in 2012, and 2/3rd off the population can take this drug. Alzheimer's drugs are on the way further increasing the number of population. Due to IP issues and rules biosimilars to enter the market, it’s unlikely many biosimilars will begin coming due to the fact that they’d have to give up certain trade secrets.

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