In an article on IAM magazine, I discuss why the United Kingdom is becoming a hotspot for the biosimilar industry.
Biosimilar development is booming. The MHRA's new approach to biosimilar approval is faster and cheaper. It no longer requires a confirmatory efficacy trial, but instead relies on a streamlined package of pharmacokinetic and physicochemical data. Taking this step now means that the MHRA are striding ahead of the EMA and FDA in this field.
The uptake of biosimilars in the UK post-launch is high and growing. While the trend may not yet mimic small molecule pharmaceuticals, it is certainly on the right trajectory.
The UK also has a series of experimental use exemptions and an SPC manufacturing waiver, allowing biosimilar manufacturers to conduct experiments for regulatory approval anywhere in the world, and also stockpile during the last 6 months of an SPC for marketing in the UK/EU.
The forum offered by the UK courts is advanced and potential new avenues appear to be opening to allow launch in the face of weak but blocking patents. Recent case law suggests that the UK court may start to take a different approach to injunctions in the life sciences sphere. There are many novel arguments on which biosimilar manufacturers can rely, particularly for life-saving biosimilars where no alternative is available. The law post-Brexit presents yet further new opportunities for creative litigants, and it will be interesting to see how the law continues to develop, particularly in relation to SPCs.
Obtaining and challenging orphan designations is also likely to be a hot topic, with questions of similarity, superiority and skinny labelling likely to be key.
The regulatory landscape, positive uptake and favourable litigation developments in the UK make this a forum to watch in the world of biosimilars.
The UK is emerging as a jurisdiction of choice for biosimilars.