The In Vivo blog reports on the disappointing biosimilar sales to date in Europe as reported during the International Symposium on Biosimilar Medicines conference held last week in London.
Biosimilars: Dead Before They Really Got Started?.
IMS generics expert, Alan Sheppard, noted that biosimilar sales in 2010 were only $235 M (with 14 approved drugs). The biggest reason cited for this is a lack of interchangeability with biosimilars and the originator drug. Substitution can only occur if a physician actively prescribes the biosimilar -- and many are reluctant to to so without more clinical data supporting their safety/efficacy in the market. This is especially true as the biosimilar has no specific advantage to offer other than a cheaper price in most cases. Innovator companies also like to apply the pressure by engaging in "life-cycle management" programs with their expiring drugs to add features like new delivery systems or longer-acting properties.
But all is not lost according to the biosimilar proponents. So far, the biosimilars that have made it to market are drugs like EPO, HGH, and GCSF. In comparison to mAbs, these are low value drugs. As the mAbs begin to hit the market as biosimilars, they'll enter less competitive markets and will support higher prices and margins -- and likely be offered much cheaper than the originator molecules. That is the plan anyway.
The BioProcess Blog also posted this week on another troubling aspect of biosimilars - this time in the US. The trouble being that the US stills lacks a clear regulatory pathway to approval -- though the FDA is working on one. Really contentious issues cited in the post include:
- Length of exclusivity period
- Use of non-US products as reference standards
- Use of proprietary drug names for biosimilars
- Substitution for the innovator
The blog's positions?
- Allow FDA to start examining biosimilar applications 4 years after the reference product's approval to allow more ready approval at the end of the 12 year (or 7 year exclusivity period)
- Allow non-US approved reference standards given that these drugs tend to be produced at one site and marketed globally. This will reduce costs of redoing trials.
- Use INN and company brand name on the biosimilar label to allow the FDA to do better pharmacovigilance with a new product until a history is built. This will slow adoption.
- Follow EU lead and make doctors specifify whether they want to prescribe originator or biosimilar drug until pharmacovigilance data is gathered
Now we await what the FDA will actually do. Their policy decision is expected "very soon" according to Commissioner Margaret Hamburg.
Posted by Bruce Lehr April 18th 2011.
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