Fil in the blanks

  • by: |
  • 01/12/2015

In October 2013, California Governor Jerry Brown vetoed a bill, overwhelmingly passed by state lawmakers that would limit automatic biosimilar substitution to those the FDA deems “interchangeable.” SB 598 also would have required pharmacists to notify physicians when an interchangeable is substituted for a prescribed biologic.

One of the Governor’s stated reasons for his veto was, “The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold of ‘interchangeability.’ Given this fact, to require physician notification at this point strikes me as premature.”

Much has changed since that day – especially per physician notification. Today even the GPhA supports this public health imperative. Perhaps the biggest change in the landscape was yesterday’s ODAC meeting on a biosimilar filgrastim – and not just the overwhelming 14-0 vote in favor, but also the FDA’s strong support of the Sandoz application.

All of a sudden the issues addressed in SB 598 don’t seem so “premature.”

But the filgrastim adcomm isn’t the end of the debate. There are still many issues yet to be determined via FDA guidance  (such as nomenclature) and corporate strategy (read, “pricing”). As BIO’s Jim Greenwood said, “This week’s advisory committee meetings facilitated important discussion of the scientific approach of reviewing biosimilar applications and we encourage this positive momentum, however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings.”

One issue that’s taking a back seat to the approval of biosimilars is the requirement for new thinking on their post-approval safety and surveillance. Biologics aren’t the new kid on the block anymore. While it’s important to pursue ways to expedite 21st century cures (as well as the eponymous legislation), it’s equally important to focus on the details of 21st century follow-on products (both biosimilars and non-biologic complex drugs). Just as the FDA has been diligently pursuing patient-centered drug development, so too must it develop new strategies and tactics (“guidelines”) for patient-centered pharmacovigilance of biosimilars and NBCDs (such as Copaxone).

It’s also time for NORD and all the other patient and disease organizations who were so wonderfully outspoken on the urgency of expediting the FDA review process for new therapies and cures to hoist the banner of follow-on safety.

On pages 21-22 of the FDA briefing documents, an agency analysis found that, statistically, the commercial variety of EP2006 (Sandoz’ biosimilar) was lower in protein content than the comparator product (Neupogen) and was nonequivalent.  FDA dismissed this as something that could be worked out with better manufacturing controls and asked Sandoz to correct it. Okay, but isn’t this exactly the kind of thing that can cause “poor responders” to filgrastim to have suboptimal responses?  An important fact to consider when debating the value of differential nomenclature for biosimilars.

And then there’s the issue of cost. Many members of Congress have been leaning heavily on the FDA to expedite biosimilar guidances so that payers can realize cost savings.

But what will those savings be?

When ODAC member James Liebmann (assistant professor at the University of Massachusetts Department of Medicine) asked what the price of the Sandoz biosimilar would be, the answer wasn’t a resounding success for those counting their savings before they’re hatched. According to Mark McCamish (Sandoz global head of biopharmaceuticals and oncology injectables development), “We can’t say that the price would be less because in some situations the price will be at parity because of other relative terms that will come into existence that’s there. Price is a relatively complex situation.”

Indeed – as is regulatory science, which is why attention must be paid to creating ever-greater clarity for both biosimilar and NBCD pathways – and in post-approval surveillance.

It’s not just about price – it’s about safety. And it’s not about getting it done fast – it’s about getting it done right. Members of Congress should be focused on greater clarity through guidances because of patient safety issues rather than vague promises of cost-savings. As Brian Harvey (Pfizer’s VP for Regulatory Strategy -- and my former agency colleague) commented, “In lieu of a finalized guidance,” the agency has been making “very good efforts” to provide case-by-case feedback about biosimilars as companies move forward.”

As Brian Harvey (Pfizer’s VP for Regulatory Strategy -- and my former agency colleague) commented, Pfizer has been “very pleased” with the frequency of its interactions with FDA regarding biosimilars and “the granularity of the feedback” the company is receiving.”

For those in the know, that’s great, but it leaves the rest of us guessing. Official guidance would be even better.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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