Industry Leaders Debate Follow-on Biologics Pathway - Pharmaceutical Technology

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Industry Leaders Debate Follow-on Biologics Pathway
The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

Pharmaceutical Technology
Volume 33, Issue 5, pp. 112-114

The bill's provisions concerning interchangeability do not recognize that, as FDA has stated, "scientific and safety issues of determining interchangeability at present are significant" and "legislation should not allow for determinations of interchangeability at this time" (1). Further, the bill does not prohibit substitution of biosimilars for innovator products without the knowledge or input of the patient and his or her physician. Physician groups, including the American Medical Association and the American Academy of Pediatrics, agree that it is essential for doctors and patients, rather than pharmacists or health insurance plans, to decide whether the innovator biologic or biosimilar would be better for each individual patient.

H.R. 1427 unfairly tilts the playing field toward biosimilars manufacturers. It provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch–Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs. Additionally, innovators would be required under the bill to share detailed information about every applicable patent with biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents. Innovators, however, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.

The approval of biosimilars should provide patients more affordable alternatives to life-saving medicines, a goal we all share. Given the complexity of biologics, Congress and FDA must be deliberative and careful in setting standards to approve products that seek to replicate proven biologic treatments. Congress should cut costs, not corners, so that no patient will have to accept greater risks when using a biosimilar.

Jim Greenwood is president and CEO of the Biotechnology Industry Organization tel. 202.962.9200,


1. F. Torti, Letter to the Hon. Frank Pallone, Jr., Sept. 18, 2008,, accessed Apr. 14, 2009.

The Generic Pharmaceutical Association's point of view

Kathleen Jaeger
The position of the Generic Pharmaceutical Association (GPhA) regarding biogenerics is simple. Biogenerics are achievable. Biogenerics are inevitable. Biogenerics are imperative. As momentum builds for the creation of an approval pathway for safe and affordable biogenerics, GPhA and the generic drug industry are committed to working with Congress and the Administration to support a workable pathway that establishes a science-based approval processes; provides for timely resolution of patent disputes; and includes exclusivity provisions consistent with the Hatch–Waxman model for traditional pharmaceuticals. The exclusivity provisions of Hatch-Waxman have fostered innovation and competition while saving hundreds of billions of dollars. This same success can be achieved with biogenerics.

As our elected officials work to reform the US healthcare system by decreasing costs and increasing access to quality care, momentum for creation of a workable approval pathway has skyrocketed.

In February, President Barack Obama's budget proposal called for a biogeneric pathway that mirrors the proven Hatch–Waxman market-exclusivity model, one that ensures that brand companies cannot extend exclusivity using "ever-greening."

On Mar. 11, US Reps. Henry Waxman (D-CA) and Nathan Deal (R-GA) introduced the bipartisan H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act. On Mar. 26, US Senator Chuck Schumer (D-NY) and others introduced companion bipartisan legislation in the Senate.

These bills are in stark contrast to the bill supported by the Biotechnology Industry Organization (BIO), the Pathway for Biosimilars Act (H.R. 1548). This act includes an unprecedented and unjustifiable nearly 14 years of market exclusivity which will tragically keep affordable biogenerics from patients in need for decades.

Contrary to what some may think, GPhA and BIO share many of the same goals when it comes to biologics, chief among them being that both organizations are committed to making sure we offer the best and safest medicines available anywhere in the world. In addition, both organizations allow sound science to drive the process.


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