Mylan’s Phase 3 clinical read out was the biosimilar show stopper at ASCO 2016. The biosimilar awareness amongst the attendees was reflected by the full house attendance of biosimilar sessions and presentations throughout the conference.
The clinical data from the Phase 3 HERiTAge study, comparing Mylan’s MYL-1401O, potential trastuzumab biosimilar and Roche’s Herceptin®, demonstrated clinical equivalence. The oral presentation made by Dr. Hope Rugo triggered discussion on its inclusion in the clinical practice and need for better value-based frameworks to consider biosimilars that do not necessarily improve efficacy but provide better costs. MYL-1401O also raised questions on the meaning of ‘sensitive patient population’, as Mylan’s drug candidate was tested in metastatic breast cancer patients and not early breast cancer patients that are otherwise considered ‘sensitive’ to HER2 treatment. As Mylan awaits marketing approval in both EMA and US, it successfully markets its trastuzumab biosimilar as Herzuma®, in several Emerging Markets including India. Amgen presented the Phase 3 study results of its ABP 215, a potential bevacizumab biosimilar, establishing ABP-215 as clinically equivalent to Roche’s Avastin®. Amgen had presented Phase 1 results for ABP-215 at ASCO 2015.
FDA and EMA came together in a single session (Biosimilars: Here and Now, 7th June 2016) to address their respective positions on issues such as biosimilarity, immunogenicity and indication extrapolation. Acknowledging the fact that physician’s education is the key to successful biosimilar adoption and that patients rely on physicians for treatment, the regulators presented a strong case in favor of the biosimilar use. They inspired confidence in the prescriber community by asking them to believe that if it is approved for marketing, it is safe to use. Their presentation included scientific data that establishes safe and effective use of biosimilar candidate on a case by case basis. The session most certainly resulted increased the interest and confidence in the biosimilar product class.
Pfizer and Amgen represented their oncology biosimilar portfolio as integrated with the NME pipeline, to communicate their position on biosimilars as an integral part of their overall oncology offerings. A satellite symposium sponsored by Sandoz and prime Oncology, addressed the key regulatory challenges, guidelines and best practices for successful biosimilar development.
Building up on ASCO 2015, the biosimilar narrative at ASCO 2016 progressed from being a far and away concept to coming soon to your clinic idea. The conversations had moved from technical issues such as characterization to regulatory pathways and clinical development considerations and real value to the society.
In growing volume of discussions round financial toxicity and healthcare burden, biosimilars were touched upon as tools to curb increasing healthcare costs and improve access. However, value-based Oncology healthcare presentations did not include biosimilars. Perhaps that can be attributed to the work in progress nature of biosimilars as a product class.
With the approval of Celltrion’s Truxima® (biosimilar to rituximab), we can anticipate the biosimilar narrative to touch upon market dynamics. We expect biosimilar developers to communicate further on their respective portfolios, achievements to-date and their differentiation from others.
RASLSS will be attending ASCO 2017 presenting our key takeaways in real-time. Watch out for this space….