FDALegislativeWatch

Biogenerics Get A Low Score From CBO, But Is BIO Actually The Loser?

The reaction of stakeholders to the Congressional Budget Office's score of potential savings from follow-on biologics illustrates the challenges for the various players as debate on legislation continues.

CBO's assessment is that follow-on biologics would save the federal government a modest $5.9 billion over 10 years - a figure that is most likely too small to re-energize negotiations this year. ¹CBO's report was released June 25, almost exactly a year after the mark-up of the bill that it analyzes, S. 1695.

That legislation, which cleared the Senate Health Committee June 27, 2007, would give innovator biologics 12 years of exclusivity and give FDA broad authority to approve follow-on products based on limited data (²"The Pink Sheet," July 2, 2007, p. 3).

Most Biosimilars Would Need Clinical Trials, ASCO Tells House Panel

While urging Congress to write legislation that allows FDA to decide which scientific data are needed to approve follow-on biologics, comments from the American Society of Clinical Oncology to a House subcommittee note that clinical trials will be necessary for most FOBs.

The Energy and Commerce Committee's health panel is considering stakeholder responses to a six-page questionnaire as it reviews options for creating a pathway to biosimilars approval (¹"The Pink Sheet," April 21, 2008, p. 22).

"FDA should be given substantial discretion in forging the regulatory pathway for approval of individual classes of biogeneric products, including determination of whether and what types of studies are needed on a case-by-case basis," according to the ASCO submission signed by Joseph Bailes, chair of the group's government relations council. For its part, ASCO favors clinical trials, noting that:

Biogeneric Exclusivity Debate: At Least 14 Years Or “Hard And Fast” Combo?

The importance of data exclusivity in ensuring that developers of biologics receive a reasonable return on investment in the face of competition from follow-on products is stressed by the National Venture Capital Association in comments submitted to the House Energy and Commerce Health Subcommittee.

Data exclusivity and patents are "complementary forms of intellectual property protection," NVCA explains in its response to a panel questionnaire on biosimilars issues (see ¹preceding story).

Patents generally are received prior to the most expensive part of drug development and may expire shortly after a product's approval, NVCA says. If a biosimilar manufacturer has access to the brand product's clinical data, the biosimilar product could come onto the market shortly after the brand product, before the patent holder can achieve a return on investment, the group points out.

Potential Federal Drug Savings Could Propel Biosimilars Bill

The potential for biosimilars to lower Medicare and Medicaid drug spending could help catalyze support for a follow-on biologics bill this year, a Capitol Hill staffer predicted at the Food and Drug Law Institute's annual conference March 26.

Congress could use lower federal drug expenditures resulting from a biosimilars bill to offset higher spending elsewhere, explained David Schmickel, who currently is on detail from the National Institutes of Health to the Senate Health, Education, Labor and Pensions Committee's Republican staff.

BIO Challenges Comparative Effectiveness Application In White Paper

All three of the major medical product trade associations are emphasizing that any comparative effectiveness program developed by the government should be enhancing physicians' judgments, but their somewhat different communication strategies illustrate the varied challenges each of the sectors face.

The Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization both note how comparative effectiveness studies can improve decision-making by doctors. However, such data should not supplant individual judgments in the care of particular patients.

FDA Gets Practical On Follow-On Biologics As Pathway Remains Theoretical

Although a pathway for follow-on biologics has not been established by Congress, FDA is offering industry a description of what some of the paving stones could look like.

BIO CEO Jim Greenwood: An Interview With "The Pink Sheet"

Biotechnology Industry Organization CEO Jim Greenwood sat down for an exclusive interview with "The Pink Sheet" at the BIO Investor Forum in San Francisco Oct. 10. Greenwood, a former member of the U.S. House of Representatives who chaired the Energy and Commerce Committee's Health Subcommittee, discusses the state of follow-on biologics legislation, concerns over pending patent reform legislation and the impact FDA reform legislation will have on the industry.

Generic Biologics Bill Still Has Good Chance For Enactment This Year - Waxman, Pallone

Two key House health legislators, Reps. Frank Pallone, D-N.J. and Henry Waxman, D-Calif., are predicting that Congress will enact an approval pathway for generic biologics this year even though FDA reform legislation pending in House/Senate conference is unlikely to be the legislative vehicle.

Comparative Effectiveness, Generic Biologics Draw Insurers' Lobbying Efforts

Comparative effectiveness research and generic biologics are among the key pharmaceutical issues that attracted lobbying efforts by large health insurers in the first half of 2007, according to reports filed recently with Congress.

FDA Review Of Follow-On Biologics Would Put Brands, Generics Under One Roof

The pending legislation to create a pathway for approval of follow-on biologics would also create a new organizational template for review of generic products.