Biologics and biosimilars are nothing new. Following the success of biologics, the first biosimilar was approved in Europe, which has a more mature biosimilar market than the US, over twelve years ago. However, it is only relatively recently that the number of biosimilars being approved by regulatory authorities has started to increase exponentially and that the real impact of biosimilars on the healthcare market has started to be realised.
The NHS Commissioning framework for biological medicines set the ambitious aim that by 2020/2021 at least 90% of new patients will be prescribed the best value biological medicine within three months of launch of the drug, and at least 80% of existing patients within 12 months, or sooner if possible, with potential cost savings of at least £200 million to £300 million per year by 2020/21. It remains to be seen whether or not this is achievable for either ‘new’ or ‘existing’ patient groups and if the estimated cost savings come true. The biosimilar industry and its market are significantly more complex than the generic small molecule market from many perspectives. Very simply, biosimilars are more expensive to make, more challenging to get approved, will likely have cost savings (but not to the same extent), and have different clinical and regulatory challenges around interchangeability, switching and substitution. The impact they can really have on the provision of healthcare is still, generally, less well understood.
Regulatory landscape
The European regulator has been blazing the trail in terms of approving biosimilar medicines. Over 45 biosimilars have been approved in Europe since 2006 and over half of these have been approved since 2017. Whilst fewer in number, the same exponential increase in approvals is being seen in the US – 12 having been approved in total, eight of which have been approved since 2017. EU and US regulatory regimes have continued to respond to increasing demands for both availability of biosimilars and for progressive, scientifically robust, approval systems, with for example, the issue of the FDA’s Biosimilar Action Plan in July and the EMA’s recent consultation on the demonstration of biosimilarity with a focus on a non-clinical physiochemical and functional data package for recombinant granulocyte colony stimulation factor biosimilars. The regulators are undoubtedly demonstrating an ability to advance progressive regulatory initiatives keeping abreast of scientific advances and improved analytics, whilst maintaining high standards of robust safety and efficacy scrutiny. This will be key to enabling both biologics and biosimilars to compete in the market.
Patent litigation landscape
The courts too, especially in the US, have been busy applying and interpreting the law around biosimilars and hearing patent challenges in this space. Innovative patent litigation strategies, arising from the landmark US Supreme Court decision in Sandoz v Amgen, are being tested and, in particular, the role of the ‘patent dance’ is being tactically considered. In Europe, which does not have a similar procedural pathway, litigation is taking a more familiar path. However, the proposed introduction of the SPC manufacturing waiver coming out of the EU incentives review is causing quite a stir, with opposing views as to whether it will provide a significant boost to the biosimilar (and generics) market.
The regulatory and patent litigation landscape for biosimilars is evolving, with many developments in the last year; and the year ahead promises to be no different.
Nicole Jadeja is a partner and co-head of Fieldfisher’s Life Sciences Practice
