Biosimilar approvals may be new to the FDA, but EMA has been approving biosimilars since 2006. The first biosimilar approved by the EMA was Genotropin (somatropin) a human growth hormone manufactured by Pfizer. Since then, the adoption of biosimilars in Europe has been strong, although it does differ by drug and drug classes with no specific pattern evident.
In 2005, the EMA provided its Guideline on Similar Biological Medicinal Products, which is the framework for biosimilar approval throughout the EMA countries. The EMA was the first body to offer guidance and since then guidance has been issued in China and in LatAm. It was not until much later, 2010, that there was any word from the FDA on guidance.
In EMA, there are four biologic classes of approved drugs:
- Erythropoietins (EPO)
- Human growth hormones (HGH)
- Granulocyte colony-stimulating factors (G-CSF)
- Anti-tumour necrosis factors (Anti-TNF)1
However, the most interesting part about biosimilars in Europe are the influencers of biosimilar uptake. The IMS Institute for Healthcare Informatics classified these clearly in their October 2014 report Assessing biosimilar uptake and competition in European markets, as:
- Healthcare budgets and financing: the over-arching influence on all healthcare market dynamics
- Payers: set the market environment that other stakeholders respond to
- Prescribers, pharmacists, manufacturers, patients: actions influenced by financing and payer decisions2
As we know, the dynamics of the healthcare market are quite involved and no one party is able to act on its own. This is apparent by the biosimilar influencers outlined above; this can also explain why the adoption of biosimilars in the EMA countries has not yet followed a specific pattern. While the organizations responsible for individual healthcare coverage in these countries have tighter control over what happens in the system (vs the US), they cannot always impact the end users views on the agents. There are mandates for the use of biosimilars in some countries, including Germany, which have quotas to drive the use of EPOs. Similarly, NICE has endorsed the biosimilar concept, which can help to drive the market there.
As we watch the launch of Zario in the United States, we also wait to see how this market will shape up; that is, whether it will be similar to the EMA or whether the US will follow its own path to biosimilar adoption.
Senior Project Director