Mar 09 2012

After all the talk, where are we with biosimilars?


Image via biosimilarnews.com

In this highly charged political climate, no news broadcast is complete without some mention of healthcare.  Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. include Humira, Herceptin and Enbrel, among others.  Blood products, vaccines, cell and gene therapies are also considered biologics.  There are no generic biologics approved in the U.S.  There are 14 biosimilar products available in the European Union (the 14 products correspond to 3 branded reference products).

Unlike drugs which are chemically synthesized, manufacturing of biologics is highly specialized, complex and very expensive.  For example, monoclonal antibodies are huge molecules derived from carefully engineered living cell cultures that have been modified to produce certain antibodies.  Biosimilars would provide a substantially similar therapeutic effect but would be produced from other cell lines.  Thus, they would be similar to, but not exact copies of, the branded product.

On 09 February 2012, the FDA issued a new draft guidance on the development of biosimilars (industry comments will be accepted until 16 April 2012).  The documents discuss the scientific and quality considerations for development of biosimilars for use in the U.S. and encourages early communication with the agency regarding development plans.  The FDA will review each product individually to determine biosimilarity, and may require nonclinical and clinical trials that show an efficacy and safety profile similar to the branded reference product.

During a 15 February 2012 webinar to review the draft guidance, the FDA said they have already received 35 requests for pre-IND meetings, and of those, 21 meetings had already been held.  They have received 9 INDs – the final step in obtaining clearance for human clinical trials.  Some trials have begun –  Hospira announced in January that a 1000-patient Phase III program of their erythropoietin (EPO) biosimilar (Epogen in the U.S.) began enrolling.  Hospira, who already has biosimilar products marketed in Europe and Australia, completed a Phase I bioequivalence testing last year, and expects results from these trials next year.

Consumers are still years away from the promised prescription savings, as a recent article states, and the savings may not be what we expected.  Biosimilar products will likely cost up to 40% less than their branded equivalent, where generic drugs can be 90% cheaper.  Since they will be biosimilar, and not exact copies, of their branded counterparts, they may not be automatically substituted for the branded medicine.  The FDA has indicated that some products may achieve interchangeable status in the future.  So far, it’s unclear what the specific requirements will be for this classification.  In the nearer term, it will also be a challenge to convince patients and their physicians that these similar products have the same efficacy as the original ones.

The market for biosimilars is expected to exceed $2 billion annually by 2015 and pharmaceutical, generics and manufacturing companies have been positioning themselves to get a piece of that pie.  Companies who already produce biosimilars for international markets and those who have already started preparing will be best positioned to take on the challenges of biosimilar development for the U.S. market.  Along with Hospira, industry analysts predict that Novartis and Teva will be on the forefront of the biosimilars movement.

This is a post by Annabel Bower, M.B.A.  Annabel is the Senior Director, Business Development Strategies at Cato Research.