The full version of this biosimilars feature can be read in the August issue of our digital magazine: http://www.pharmtech.com/ptedigital0810
Many hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies
will be asking themselves when entering the biosimilars arena:
• Can highly comparable biological products be manufactured to exacting quality standards? Given the depth of knowledge involved in the creation of the originator product and advances in both analytical techniques
and protein manufacturing this is highly complex, but it is achievable.
• Can the requirements of the European regulators be satisfied? The guidance from the European Medicines Agency (EMA) on Chemistry, Manufacturing and Controls (CMC), nonclinical and clinical
aspects is very clear, and several biosimilar products have already been approved — including human growth hormones, erythropoietins
and granulocyte colonystimulating factors. The stringent requirements of regulators are highly complex and significant expertise
is also required to complete the necessary extensive clinical programmes. However, all of this is achievable.
• Can products be commercialised once they reach the market? This question often receives less attention compared with the previous two questions, even though successful commercialisation
is vital for the longterm viability of each product, as well as the biosimilars market as a whole. There is little documented
evidence about effective commercialisation strategies. The main obstacle to overcome initially is the restrictions placed
on pharmacy substitution of an originator drug with a biosimilar — either for legal or clinical reasons. Therefore, successful
commercialisation will depend on winning the acceptance of clinicians to interchange their prescribing of originator products
for biosimilars. This will require investment in clinical detailing infrastructure.
To make the situation more difficult, biosimilar manufacturers are also faced with the actions of the originator companies
who are desperately fighting the introduction of biosimilars. This is usually done through communication to key influencers
and decision makers, with much of their efforts directed at raising doubts over the safety of biosimilars. The evidence against
biosimilars that has been cited by innovators often presents a distorted picture. For example:
• Comparison of isoforms shows a major difference between biosimilar and originator products. The evidence came from different biosimilar products sourced from Asia and did not address the very high quality requirements
for biosimilars in the EU.1 None of the biosimilar products were registered in Europe.
• Biosimilars may cause serious safety issues. It is possible that small changes in the manufacture of a biological product could lead to immunogenicity problems, an example
being Johnson & Johnson's Eprex in the late 1990s/early 2000s, when the drug was linked to cases of pure red cell aplasia.
However, immunogenicity is an issue related to all biopharmaceuticals — whether they are originator or biosimilar products.
The main benefit of a biosimilar product is its ability to help reduce the cost of care for patients, while at the same time
maintaining the level of quality, safety and efficacy experienced with the originator medicines. This should enable more patients
to be treated or may help to fund the use of a newer, highcost therapeutics. Biosimilars may also provide improvements over
the originator product for example by incorporating improved safety devices, tamper evident packaging and improved data in
the package information.
Despite the potential advantages offered by biosimilars, healthcare professionals have generally been cautious about introducing
them into their practice — mainly based on anti-biosimilar communication both before and since their introduction. Many clinicians
have waited until experience from other countries or hospitals proves the quality, safety and efficacy of biosimilars, and
we are starting to see increasingly strong adoption over time.