Interchangeability of biosimilars

August 16, 2011 2:11 PM

After the elections in the US, healthcare reform was one of the top priorities and it was brought in to force in March last year. After long debates, with this reform, a pathway for marketing approval of biosimilar products was allowed.

The Biologics Price Competition and Innovation (BPCIA) was included in this pathway and an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars was established last year.

Since then, drug manufacturers are waiting the guidance on a biosimilar approval pathway in the US and some opinions about the ongoing discussions was recently published in NEJM, written by the FDA officials.

The Biologics Price Competition and Innovation Act gives the FDA the authority to designate a biosimilar as interchangeable with the reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without the opinion of the prescribing physician.

This automatic substitution, will probably enable biosimilars to be adopted much more rapidly than the EU. In the EU, EMA does not have the authority to designate biosimilars as being interchangeable with the reference product and interchangebility is not widely accepted in the EU member states for the time being.

The key European markets France, Germany, Italy, Spain and the UK forbid automatic substitution. And lately, Norway delisted filgrastim from the substitution list and automatic substitution for biosimilars is forbidden after a court decision.

With the interchangeability, patients access to these often life-changing medicines will increase and healthcare costs for both patients and governments will be reduced more rapidly.

Both innovator companies and patient advocacy groups in the US have objected to this automatic interchangeability, stating patient safety as the reason; minor changes in the manufacturing process can impact on the safety and efficacy of a drug. It was also suggested that, substantial clinical testing for biosimilars should be made and any interchangeability determination should be delayed until post-marketing studies have been conducted.

On the other hand biosimilar manufacturers argue that FDA is already equipped to make both biosimilarity and interchangeability determinations. They discussed that, differences exist within different batches of reference products and FDA has already allowed the interchangeability between the originator batches.

Since the US Congress is also intent on making low-cost biosimilars available to patients, it intended something less than full clinical trials for approval of biosimilars. Taking into account patient safety, it is therefore clear that the FDA rules will likely to be less stringent than a Biological License Application and if interchangebility is fully accepted, the market for biosimilars in the US will probably have the best growth rate in the world.


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