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From IPW's Kiernan Murphy and Kaitlin Mara:

"Key players in the biotechnology industry are leading an effort to obtain global approval processes for generic biological medicines, which experts say could provide cheaper access to costly but widely prescribed and promising treatments.

These highly complex medicines, many of which have recently or will soon come off patent, are difficult to produce and reproduce and highly expensive to purchase.

This raises questions about how patients can access these cutting-edge technologies, and whether the creation of generic versions – called biosimilars, biogenerics, or follow-on biologics — is feasible. Key issues with biosimilar creation include the question of who owns the right to use data from clinical trials, and whether it is possible to make versions of such complex products similar enough that they can be substituted for the brand-name originals.

The term biologics generally refers to protein-based medicines, as opposed to chemical based medicines, and their production involves genetic manipulation and large-scale cultures of living cells rather than chemical synthesis. This means that “biologics are inherently much more difficult to copy and to replicate than small-molecule products,” said Hans Sauer of the Biotechnology Industry Organization (BIO). Slight modifications to the production process may induce biologics to behave differently.

The Center for Biologics Evaluation and Research, part of the US Food and Drug Administration, notes that biologics are often “at the forefront of biomedical research” and “may offer the most effective means” to treat medical conditions “for which no other treatments are available.” They also cost on average twenty-two times more per daily dose than traditional chemical medications, according to a 2008 paper by Boston University economics professor Laurence Kotlikoff [pdf].

What constitutes appropriate regulation for these new technologies is still being considered, and multilateral discussion is still in its fledgling stages. Outcomes arising from select areas of the world - the recent European guidelines or the result of the current US debate - are likely to shape international policy on these issues.

Thus, debates over regulation of and access to biologics are set to become increasingly important. In the United States, this has been primarily an “industry versus industry fight, brand name versus generic,” said Sarah Rimmington of think-tank Essential Action.

However, Sauer said lines between these stakeholders are blurring, with a “pretty diverse field of industrial participants” — from classic generics companies to emerging biotechnology companies to the traditional innovator companies — interested in biosimilars." (