BIOLOGICS
Parties seeking to market a follow-on biological product in the US traditionally have had two options for obtaining Food & Drug Administration (FDA) approval of their product. With the passage of the Biologics Price Competition and Innovation Act last year, there is now a third option. Paul Calvo and Timothy Shea explain the key advantages and disadvantages of each.
Follow-on biologics, new versions of previously approved biopharmaceutical products intended to mimic the therapeutic effect of the approved product and compete for market share, have been approved by the FDA either as completely new biological products requiring submission of a full Biologics License Application (BLA) or under section 505(b)(2) of the Federal Food Drug and Cosmetic Act. With the passage of the Biologics Price Competition and Innovation Act (BPCI) in 2010, follow-on biologics manufacturers were presented with a third, abbreviated, pathway for approval. Each alternative has specific requirements and certain advantages and disadvantages compared with the others. Entities considering bringing a follow-on biologic to market must carefully consider the relative pros and cons of each route in determining which is best for a given product. While the cost of clinical trials and the possibility of data or market exclusivity will oſten be the primary considerations, manufacturers should also consider factors such as the nature of differences between the follow-on product and the approved product, the likely potential market share the follow-on will capture and the desire for patent certainty at the time of launch.
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Biosimilars (including interchangeables)
Te BPCI introduced, for the first time ever in the US, an abbreviated approval pathway for follow-on biological products deemed to be ‘biosimilar’ to a previously approved biological product. In order to qualify as a biosimilar, the biosimilar applicant must demonstrate that their product is 1) highly similar to the reference product, i.e. the approved product, notwithstanding minor differences in clinically inactive components, and 2) there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency. A primary advantage of the new abbreviated pathway for biosimilars is that the biosimilar applicant is able to rely on the safety and/or effectiveness data of the previously approved biologic (the reference product). In theory, this will significantly reduce the amount of clinical data that must be submitted to obtain approval, and therefore reduce the time and expense required to obtain approval of the biosimilar product. Moreover, biosimilar products that meet the heightened standard of being interchangeable with the reference product are deemed automatically substitutable with the reference product and are entitled to a limited
period of post-approval market exclusivity. Yet another advantage of the biosimilar route is that the BPCI provides for a patent dispute resolution procedure that provides the biosimilar applicant with a statutory mechanism to challenge the reference product sponsor’s patents and obtain some degree of patent certainty prior to actual launch of the biosimilar product.
Te biosimilar route, however, also has a number of limitations. First, the BPCI is new and, at the time of going to press, the FDA had not yet issued any regulations to implement the law. Second, in contrast to the abbreviated approval pathway for small molecules established by the Hatch-Waxman Act, the biosimilar pathway will require, at least for the time being, significant clinical trials to be conducted by the applicant. Te regulatory details of the pathway remain to be defined and the anticipated reductions in the amount of clinical data and time needed to obtain approval remain unclear.
Another limitation is that the period of market exclusivity provided by the statute is only available to the first biosimilar product deemed to be interchangeable with a given reference product (as opposed to the first product that is
World Intellectual Property Review May/June 2011 29
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