Lack of credibility in the prescribing community
In Europe the first biosimilars gained approval only four years ago, in 2006 and regulations for biosimilars in the US are
still undetermined. Overall, for western highregulated markets, clinical experience per biosimilar is limited to a couple
of years at best. This very limited experience is a contrast to the longterm experience of the respective originator drugs.
The prescription decision and, in the absence of automatic substitution mechanisms, also the purchasing decision, is most
likely to be taken by the treating medical doctor. Because the biosimilar cannot positively differentiate itself on efficacy
or safety, the argument of an advantageous price - on which the prescriber does not earn a penny — will not compensate the
disadvantageous lack of clinical experience of the biosimilar. Thus, the healthcare community applies a healthy scepticism
I do believe this scepticism can, be overcome. At Finox we are convinced that credibility in the prescribing community will
not be gained by what we say, but by our actions in the provision of a sound product for the market. Regulations for drug
development often offer room for interpretation — in short, you can go the easy (eventually more risky) way or you can challenge
yourself by taking the rough ride. We believe that the tougher we set the specifications we want to achieve with our biosimilars,
the more credibility we build for our products and the more potential we have of selling them. If a company goes the extra
mile while developing a biosimilar, we are convinced that the extra time and money spent will save on marketing expenses postapproval.
It is advisable to catch the interest of the prescribing community early on and to sustain this interest by asking them to
share their view of a perfect product offering. These views should then be built into the target product profile. Although
there is only limited room for differentiation of a biosimilar, this limited space should be occupied by developing a product
offering that is more focussed on the prescriber's and the patient's needs compared with the originator. After having spent
a lot of money on the development and approval of the biosimilar, overcoming the credibility hurdle when entering the market
amounts to another substantial investment. For a small company, this might be too difficult to bear. I expect to see various
types of partnering activities between small development-oriented companies and larger pharma firms; the latter being responsible
for market access for the product and providing credibility through its established product lines and brands.
Lack of credibility in the policy forming community
The European Medicines Agency (EMA) requires extensive non-clinical and clinical comparability data between the biosimilar
and the originator as well as interchangeability and immunogenicity assessments after repeated use. However, automatic substitution
at the dispenser's desk is still not a market reality. So long as the clinical experience with biosimilars is as limited as
it is today, the implementation of automatic substitution by the policy forming community will not take place. The absence
of automatic substitution has two effects for the biosimilar market: first, it is a selffulfilling argument as it allows the
originator industry to keep alive their myth of non-similarity of biosimilars; second, it creates another hurdle for the market
penetration of biosimilars.
Lack of credibility as an industry
The biosimilars industry is an emerging industry that has not yet proven its long-term viability. Therefore, the supply side
of the biosimilars market still has a long way to go to convince the demand side and the regulator that it is a valuable partner.
This lack of industry credibility also dilutes the strength of the biosimilars industry in its interactions with these market
stakeholders. The more regulated a market and its industry, the more important lobbying by the stakeholders becomes in order
to influence policy setting in their favour. The biosimilars industry has an inherent interest in building up more credibility
because this will allow it to further influence policy outcomes aligned with its interests.