With the ink now dry on the Biologics Price Competition and Innovation Act of 2009, the reaction by likely applicants has, not surprisingly, been mixed, with some companies eschewing it, some embracing it and others adopting a wait-and-see approach.
Sandoz, for example, has opted to pursue approval of biosimilars through traditional channels, such as BLAs and paper NDAs, instead of facing two perceived risks of filing for approval under the Act. The primary risk Sandoz cites is that the Act requires very early disclosure to relevant pioneer companies of biosimilar applications and “other information” relating to the imitator’s manufacturing processes, which, according to Sandoz, affords pioneers the opportunity to “pick apart [imitator] arguments scientifically and on the patent front to leverage in their own litigation against [imitator firms]” years before the imitator product comes to market. See “The Pink Sheet,” May 3, 2010, at p. 7. Additionally, Sandoz notes that the Act does not require patent litigation resolution prior to approval of a biosimilar, which could result in prolonged patent litigation and substantial additional costs to the imitator. See id.
By contrast, it has been reported that Merck has filed or is planning to file an application with the FDA via the new biosimilar approval pathway. According to Merck BioVentures President Michael Kamarck, “[w]hen regulators create a pathway like this one they are actually asking you to help them, to really carve what the space looks like. We see that only as opportunity.” See “The Pink Sheet,” July 5, 2010, at p. 3.
Teva, Pfizer, Genzyme and most other companies have adopted a wait-and-see strategy for filing biosimilar applications under the Act. Teva, for instance, is currently utilizing the BLA process for its biosimilar products, but the president and CEO of Teva North America, Bill Marth, said “[a]s the FDA determines the process for filing an abbreviated BLA, we will continue to evaluate what pathway we take on a protein-by-protein basis.” See “The Pink Sheet,” May 3, 2010, at p. 7.
Many thought that an abbreviated biosimilar approval pathway would significantly alter the biopharmaceutical industry, but the Act has had minimal impact to date, likely because of stakeholders’ mixed reactions and because the FDA has yet to issue guidance on how it will implement the Act. Regarding the latter, and as noted in this newsletter, the FDA held a public hearing on November 2-3, 2010, to solicit comments on how approval of biosimilars should be effected. Electronic and written comments are also being accepted by the FDA until December 31, 2010. Until the FDA can digest this commentary and issue its guidance, it is unlikely that a majority of biopharmaceutical companies will participate in the new approval process.