Jeff George, the head of Sandoz (not the former NFL quarterback), predicts using existing regulatory pathways (like 505(b)(2) or a BLA) to bring FOBs to market rather than use the new regulatory pathway provided in the health care reform legislation. Why? Because provisions in the new pathway that favor the innovator brands.
According to the Pink Sheet, “Generic drug makers applaud passage of the legislation, but some including Sandoz, are under-whelmed by the opportunity the legislation provides.”
Mr. George: "The devil's really in the details." He focuses on three issues:
(1) The provision for an FOB manufacturer to give its application to the innovator company to facilitate patent infringement negotiations. The health care reform legislation requires that biosimilar applicants provide the reference product sponsor with a copy of the application and "other information that describes the process or processes used to manufacture the biological product" within 20 days after FDA accepts the application for review.
(2) The reference product sponsor is then expected to provide the biosimilar applicant with a list of patents for which it thinks it could claim patent infringement, and each company is expected to lay out its legal basis and ultimately negotiate and reach a resolution on which patents to litigate.
Mr. George: "I think it is unfair to generic companies that we would be required to hand over our dossiers to our competitors years before the product comes to market in order that they could pick apart our arguments scientifically and on the patent front to leverage in their own litigation against us.”
(3) The legislation does not require litigation resolution, opening the door to years of patent litigation, even after FDA approves a biosimilar. "Effectively, it calls into question why you would use this pathway if you've got to hand over your scientific dossier to your competitor on the one hand and your competitor can tie you up in litigation," George said. "With that kind of pathway, it's not clear that companies like Sandoz and the leading generic (sic) companies in the world would use this pathway to go to market.”
Sometimes a taste of your own medicine is good for the soul.
And, on an unrelated note, one word – Provenge.
