The year 2015 marked the approval of the first biosimilar via the BPCIA pathway in USA. The murmurs of biosimilars could be heard in the corridors of ASCO-2015. A total of 3 clinical read-outs and industry sponsored activities marked the largest oncology congregation of 2015.
Russia-based biosimilar developer, Biocad presented Phase 3 clinical data of its potential bevacizumab biosimilar. The candidate drug, BCD-021, demonstrated equivalence to Avastin® (marketed by Roche) in a comprehensive comparability exercise that included physicochemical, PK and PD studies, as well as Phase I PK clinical study in patients with Non-Squamous NSCLC. The clinical non-inferiority data led to the approval of Avegra® (Biocad’s bevacizumab biosimilar) currently being marketed in Russia and other Emerging Market countries. Amgen presented Phase 1 data of its potential bevacizumab biosimilar ABP-215. Pfizer presented Phase 1 clinical result of its potential trastuzumab biosimilar PF-05280014 in healthy volunteers. The data indicated favorable circumstances for larger clinical equivalence trials for both the products. Taken together, the three data presentations created a sense of biosimilars as an emerging tool, in the oncologists’ repertoire against cancer. The discussion and awareness around biosimilars was further accentuated by the presence of industry sponsored sessions within and outside of the ASCO perimeter. Biosimilar leaders such as Hospira, Amgen, and Sandoz delivered fundamental presentations on biosimilars addressing FAQs such as similarity, interchangeability, indication extrapolation, immunogencity etc. Hospira communicated its credibility based on its biosimilar experience in European markets. Sandoz reiterated its pioneer position in Biosimilars by virtue of the first biosimilar approved in US – Zarxio®. It restated affordability and accessibility as the two promises of biosimilars. In a sponsored session, Sandoz presented data for its rituximab biosimilar, to help build a broader understanding of the concept of biosimilarity via analytical characterization and “fingerprinting”.
In the booth area, there were two distinct communication camps – Traditional Generics Developers and Innovators. Companies like Sandoz and Hospira actively communicated their involvement in biosimilars and sought to engage the stakeholders eagerly. Innovators were understated in their communications – Amgen refrained from any direct communication of its biosimilar portfolio. Merck concentrated on its immune-oncology drug, Keytruda®. Pfizer showcased its biosimilar portfolio as integrated with the NME pipeline without any specific emphasis.
ASCO 2015 resulted in a very positive narrative for biosimilars with active participation from all stakeholders. The overarching theme of ‘value creation for patients’ opened discussion on the cost-effectiveness of current and future treatments. By the end of the 5-day meeting, biosimilar emerged as a clinically viable and a cost-effective treatment option for both patients and prescribers.