The promise of health care savings from an abundance of biosimilar drugs brought to market under recently passed reforms may go unfulfilled if intellectual property provisions of the law aren't addressed, members of a panel at the BIO annual meeting in Chicago said May 5.

While FDA was offered a seat on the panel, focused on implementing a biosimilar pathway, the agency responded that it is not participating in any panels on the topic, moderator Bruce Artim, director of federal affairs at Eli Lilly, said.

FDA has formed a working group to address the new law, CDER Deputy Director Doug Throckmorton said during an earlier FDA Town Hall session. Co-chaired by CBER Acting Director Karen Midthun and CDER Director Janet Woodcock, the cross-center group is tasked with establishing the policies and procedures to be used in formulating guidance and in rule making "to implement the intent of Congress," Throckmorton said.

Midthun told a Sandoz representative in the audience, who asked for a timeline on the implementing regulations, that the agency is only just beginning to assess how to focus its efforts and what the priorities might be.

Imitators Wary Of Patent Challenge Pathway

The main impediment to the success of the legislation, however, appears to lie not in any science-based regulations being formulated by FDA, but in the pages and pages of patent challenge provisions laid out in the new law.

Under the law, drug makers must first invest in developing a biosimilar and submitting it for approval before they can discover whether they will run into patent challenges from the innovator company. To do that, they are required to submit their complete dossier to the innovator company, which examines it and responds as to whether its patents are being violated (¹ Also see "Biosimilars Pathway: Lack Of Orange Book For Patents Worries Momenta" - Pink Sheet, 10 May, 2010.).

"People will tell you there are all kinds of safeguards," Momenta CEO Craig Wheeler said. But, the process is "fraught with all sorts of issues."

Big generics companies like Teva and Novartis' Sandoz division have already eschewed the new pathway. Sandoz CEO Jeff George has announced that there are "caveats that preclude its use" despite "very interesting and very nice provisions," panelist Mark McCamish, Sandoz global head of pharma development, noted (² Also see "Sandoz Will Steer Clear Of U.S. Biosimilars Pathway, Use Other Applications" - Pink Sheet, 3 May, 2010.).

The Centers for Medicare and Medicaid Services are "concerned companies might not use this route," McCamish argued.

The potential for savings from biosimilars is not a grand part of health care reform calculations - the Congressional Budget Office pegged it at $6 billion or $7 billion in lower payouts from CMS over the next 10 years (³ Also see "Pediatric Exclusivity For Brand Biologics Added In Senate FOB Provision, But Generics Have $1 Bil. In Leverage From CBO Score" - Pink Sheet, 30 November, 2009.).

But, during the debate on the development of the pathway, the generics industry argued that the savings from follow-on biologics could be much more substantial, even twice as high (⁴ Also see "Biogenerics Get A Low Score From CBO, But Is BIO Actually The Loser?" - Pink Sheet, 30 June, 2008.).

But as the tide of the debate turned against them, generics firms said that the pathway taking shape would be essentially worthless. Which prediction comes to pass probably will dictate how much tinkering Congress eventually does with the pathway.

Fix Unlikely Near-Term

Having endured debate over biosimilar legislation for the better part of a decade, Congress is not likely to reopen that particular can of worms soon in order to fix the off-putting IP provisions.

There are fixes, but chances are "the legislative will to be able to reopen this is very low," quipped Artim, a former chief counsel for the Senate Judiciary Committee.

Nonetheless, "Congress wanted to do this to bring in lower-cost competition, and if it fails, it seems like there would be a lot of interest" in fixing it, countered Jay Siegel, Johnson & Johnson chief biotechnology officer and head of global pharma regulatory affairs.

- Shirley Haley ( ⁵ s.haley@elsevier.com )

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