Abstract
This was the Center for Business Intelligence’s 2nd Annual Summit on Biosimilars. The participants included industry, government, academics and private professionals involved in the myriad issues of biosimilars. Its purpose was to present a dialogue to evaluate the legal, regulatory and economic landscape in the USA and abroad and prepare for the anticipated US legislation that will enable the entry of biosimilars. Another conference will be held in September to discuss the various pending biosimilar bills in more detail or the new law, if passed.
Gillian Woollett from Engel and Novitt (Washington DC, USA) was the chairperson of the conference, which centered on the anticipated legislation to allow biosimilars to enter the US market. Currently, for the most part, no entry pathway exists for biosimilars in the USA. However, in Europe, legislation has been established to allow for entry, and this has enabled entry to actually occur. The major issues are what the US legislation should consist of in terms of safety and technical requirements, its potential impact on innovation with respect to patents and data exclusivity and the competitive effect of entry.
Susan Kirshner from the US FDA examined the various factors that are essential to determine the similarity of biosimilars. In discussing the safety issues, the focus was on the relationship between protein attributes and clinical activity, as well as the factors that need to be considered when deciding the similarity between branded products and biosimilars. In addition, the quality impact of source materials and manufacturing processes was discussed.
A panel discussed the technical, analytical and regulatory requirements needed to assure the safety and effectiveness of biosimilars. This includes an understanding of the analytics and technical requirements. Currently, there is no standard in the USA on how alike the branded and biosimilar must be for the biosimilar to be approved. The assessment of the data required for approval and the role of comparability are also important issues.
Another panel discussion posed questions regarding the most suitable public policy with regards to biosimilars. It analyzed the current and changing status of proposed legislation in the USA and provided a comparison of the different bills. It also discussed the possible outcomes, especially with regards to the FDA’s role in the biosimilar process. Topics such as clinical trials, interchangeability and post-market evidence were examined.
Brian Finlay of the Henry L Stimson Center (Washington DC, USA) analyzed the possible entry of biosimilars into Canada. The Canadian legislative process and how it differs from that in the USA was discussed, as well as the effect of a newly re-elected government in Canada on the entry of biosimilars.
The WHO recognized the need for a consistent policy worldwide for the approval of biosimilars (Washington DC, USA). The WHO Global Biosimilar Guidelines were discussed by John Engel of Engel and Novitt. The issue of the possibility of a globally accepted biosimilar standard was addressed, as well as the implications of the WHO guidelines on the global marketplace. The goal of the WHO guidelines is to provide increased access to biosimilars worldwide at a reduced price.
Elizabeth Jex of the Federal Trade Commission (Washington DC, USA) gave insights from a Federal Trade Commission roundtable that was held in November 2008 and concerned the competitive impacts of biosimilars. The roundtable’s objective was to determine the proper balance between innovation and competition. The important issues of when patent resolution should occur and the competitive effects of biosimilar entry were analyzed.
Kurt Karst from Hyman, Phelps and McNamara (Washington DC, USA) examined the patent provisions of the various bills currently pending in the USA. The differences between biosimilars and Hatch–Waxman patent provisions were analyzed, as well as the issue of whether the Orange Book should be used for biosimilars.
A panel considered the length of and implications of data exclusivity. The panel differed on the appropriate length for data exclusivity. The economic and social consequences of different exclusivity periods were discussed. An important issue related to data exclusivity and the incentive to innovate involves the strength of biopharmaceutical patents.
Another panel examined the issue of exclusivity for the first filer of a biosimilar. This Hatch–Waxman provision has provided generic firms the incentive to challenge patents but has led to some unintended consequences that have antitrust implications. The panel discussed possible ways to avoid these antitrust issues in the legislation concerning biosimilars.
James Doyle from Axinn, Veltrop and Harkrider (NY, USA) examined how both the innovator and biosimilar firms should prepare for the inevitable patent litigation that will follow after the biosimilar law has been passed. The issues of innovators’ structuring their patent portfolio to maximize exclusivity and biosimilar firms’ strategy for patent challenges were analyzed. The lessons from previous pharmaceutical cases were examined as a framework for the future.
The potential economic impact of biosimilars was examined by Joseph Fuhr of Widener University (PA, USA). The risk of entry and economic performance of biopharmaceutical companies were analyzed. The difficulty and the risk of entering for biosimilars, including issues such as manufacturing, substitutability and the cost of entry, were discussed. The lower discounts of only 20–30% and higher costs will result in a smaller competitive advantage than in generic markets. In addition, the early experience of biosimilars in countries where entry has been allowed was recounted.
A panel discussed the important issue of different lengths of exclusivity and how they will affect the incentive to innovate and the economic implications. This is especially important in light of the strength of patent issues in the biosimilar market.
In conclusion, the conference focused on the important issue of pending legislature concerning biosimilars. The two main foci were safety and effectiveness and the economic issues. In terms of safety, the main issue was how a law could provide for a system to assure that biosimilars are both safe and as effective as the innovative drug. The economic issue is balancing the incentive to innovate with competition, which will lead to lower prices and greater access to biopharmaceuticals.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.