Economic Analysis of Availability of Follow-on Protein Products. Selection of Candidates for FoPPs


In order to identify likely candidates for FoPPs, we first examined broad categories of biological products (e.g., erythropoietins, monoclonal antibodies for cancer). We used searches of the Internet, published literature, and other sources (e.g., market research reports) to locate relevant information regarding these groups of products. In addition, we completed several semi-structured interviews with experts from federal agencies as well as industry, academic, and policy-support functions (e.g., health economists).

The review of biologic categories focused on the top 10 categories of biologic products, which are listed below in descending order according to 2006 annual sales.[49]

  1. Erythropoietins (EPO)
  2. Cancer monoclonal antibodies (MAbs)
  3. Anti-tumor necrosis factor (anti-TNF) agents
  4. Insulin and insulin analogs
  5. Recombinant coagulation factors
  6. Interferon beta
  7. Granulocyte-colony stimulating factor (G-CSF)
  8. Human growth hormone (hGH)
  9. Interferon alpha
  10. Enzyme replacement

Each biologic category was examined with regard to the following criteria, listed in their general order of importance:

  • 2006 annual sales
  • US regulatory route (i.e., Public Health Service Act vs. FDCA)
  • Market factors (e.g., patent protection, second generation products)
  • Presence of an approved FoPP in the US/EU
  • Indication(s) and approximate size of affected population
  • Growth rate in sales from 2005 to 2006
  • Estimated influence of FoPPs (as measured in a recent survey)[50]
  • Issues regarding the scientific feasibility of developing FoPPs

The results of this review informed the selection of a subset of biologic categories for further consideration. We considered individual biologics within these selected biologic categories. We considered only those biologics that ranked in the top 20 biologics according to 2006 annual sales, in order to ensure that candidates selected would have a sufficient economic impact. Individual biologics were examined using the following criteria:

  • 2006 annual sales
  • US market share
  • US patent expiration
  • Presence of an approved FoPP in US/EU
  • FoPPs approved or under development in other countries

While scientific feasibility is discussed as a potential barrier to synthesizing FoPPs (it is generally the case that biosimilarity is more difficult to prove in larger, more complex molecules), economic and clinical/scientific experts in this field have suggested that, if the markets are large enough, companies interested in developing FoPPs are likely to overcome scientific hurdles.[51],[52],[53],[54],[55] Further, there is some variability within and across biologic categories with regard to the complexity of specific molecules. For example, in some instances, a recombinant coagulation factor can be more complex than an EPO and an EPO can be more complex than an MAb, reflecting a spectrum of complexity across biologic categories related to molecular size, protein folding, and addition of subgroups and side chains to the core molecule.[56] Due to the ambiguity of scientific feasibility in the creation of FoPPs, this factor did not figure strongly in the review of likely candidates.

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