Patient access to biologics can be restricted in Western countries and virtually unreachable in developing countries. Regulatory legislation varies regionally, but most countries have now established or adopted formal biosimilar guidelines to pave the way for biosimilar approvals. This section takes a closer look at biosimilar development at the regional level, including access to biologics, regulatory guidelines, biosimilar approvals to date, and potential savings.
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Biosimilars have been approved for a total of 18 different originator biologics in highly regulated markets around the world as shown in the table below. Please check the website regularly for new developments in regions of interest.
Updated February 2018
|Biologic||Australia||Canada||European Union||Japan||South Korea||United States|
|Follitropin alpha (FSH)
*Approved via 505(b)(2) pathway before the dedicated biosimilars 351(k) pathway was established. In 2010 the FDA also approved a low molecular weight heparin (LMWH) via 505(b)(2) but considers this a generic rather than a biosimilar (a view the EMA does not share)
**One or more of these is licensed under two brand names from the same manufacturer
†Three later withdrawn within EU for commercial reasons (two filgrastim, one somatropin)
ǂSeveral brands of somatropin are available in Australia, most of which pre-date the biosimilars regulatory pathway
This table does not include all markets that have adopted biosimilar guidelines, but lists those that are generally recognized as frontrunners with biosimilar legislation and licensing. In developing countries like China, Russia, and India, formal biosimilar regulatory frameworks have now been introduced but it is important to note that numerous follow-on biologic products – often referred to as biosimilars in the media and the literature – were approved before this time. Because these products have generally not been developed according to rigorous international standards, they should be regarded as “copy biologics” rather than biosimilars. The same situation applies in many Latin American countries.