Last week London had a pretty good weather, slightly chilly evenings and surprisingly, sun-kissed mornings! Yes, we were there to attend the 5th Biennial Biosimilars & Biobetters Congress in London (since the event was in London. I guess it’s a mandate to start with a weather update J)
It was a two-day interactive event addressing various topics including market access strategies, clinical development, opportunities and commercial challenges amongst others. However, I will keep it short and focus only on the key takeaways from the congress.
Being in the business of biosimilars consulting, we have attended several conferences in the past (this was my first ever international conference on biosimilars). One of the most notable aspect of the conference – the discussions have evolved from being technically focused (manufacturing, structural similarity, analytical characterization, clinical equivalence) and hazy regulatory guidelines (for clinical development) and patents, to a very clear guidance on path to market and to a lesser extent, differentiation.
The 2018 conference focused on market access strategies, country-specific efforts to incentivize biosimilars development (UK’s NHS efforts in England) and a panel discussion of what could the future for biosimilars look like. In UK, the uptake of biosimilars has been fairly remarkable. The NHS has a put a framework in place to integrate biosimilars treatment into routine practice and has further declared its plans to support commissioners, prescribers, providers and patients (aims to deliver savings of GBP 200-300m annually by 2020-21).
There were a few attorneys amongst the speakers discussing patents and the regulatory environment for biosimilars. The general consensus was that US lags behind EU in biosimilars approvals (something we are already aware of) due to several issues including patent settlement, formulary placement and coverage restrictions (meaning biosimilar may not be reimbursed for all approved indications of the reference product).
Apart from discussions on interchangeability, real-world evidence (in the context of risk management), biosimilar cell lines and process development, there was a very interesting panel discussion on the future of biosimilars (to me this was the highlight of the event). One of the panelists was Dr. Steinar Madsen from the Norwegian Medicines Agency (you may have heard of him if you have previously attended any biosimilars conference). The impressive uptake of biosimilars in Norway has become a big industry talking point and given Dr. Steinar’s role in the growth of biosimilars, he has become one of the foremost experts in this space. He spoke about interchangeability between the reference product and biosimilars and interchangeability between the biosimilars. The panel also anticipated that 5 to 10 years hence, biosimilars could gain regulatory approval based on PK/PD data without a Phase 3 study.
While there was a lot that was discussed during the two days of the congress, these were the key notes from the sessions (keeping it short as I promised). In summary, EU has let data and science govern the path for biosimilars (with 29 approvals), while the US is stuck in the language of statue which has governed its biosimilars market (with 9 approvals).
Despite the recent changes in the Trump administration and the soon-to-be-issued FDA’s ‘Biosimilar Innovation Plan’ in 2018 for the US, the uptake of these specialty medicines is yet to be seen. This lag is also a concern that was expressed by nearly all the attendees citing the importance of US market for biosimilars.
While we have to wait and watch as to how will the competitive dynamics for biosimilar developers look like in the future (when we will have several biosimilars launched for the same reference product). We at RAS LSS posit that biosimilars market trajectory will soon reach an inflection point as it relates to (a) regulatory uncertainty (b) uptake (c) fierceness of competition and will stabilize soon after, to look similar to a small molecule generic market, with automatic substitution as a rule, and not an exception.