Industry Leaders Debate Follow-on Biologics Pathway

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Pharmaceutical Technology, Pharmaceutical Technology-05-02-2009, Volume 33, Issue 5

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

The Biotechnology Industry Organization's point of view

Biotechnology has created hundreds of breakthrough therapies and treatments for patients suffering from debilitating diseases such as multiple sclerosis, diabetes, and HIV/AIDS. We are developing new innovative therapies and treatments for unmet medical needs and rare diseases. And we are providing a link between the hope provided by stem-cell research and the reality of treatments and cures for patients.

Jim Greenwood

Even with the dynamic evolution of our industry in recent years, we have our work cut out for us: we need to ensure that all Americans have access to these life-enhancing and life-saving medicines.

Congress is considering legislation that could help expand access to biologics. These proposals would enable companies to produce biosimilars, products that are similar to, but not the same as, pioneering biotechnology therapies. A healthy biosimilars market could help increase access to biologic treatments by lowering costs and increasing choice. But Congress should proceed with caution—missteps on the path to developing biosimilars could jeopardize the safety of patients as well as future biomedical innovation.

Biologics are complex therapies developed from living cells and organisms. The slightest change in manufacturing processes can impact the safety, purity, and effectiveness of a biotech medicine. As the US Food and Drug Administration has recognized, these drugs are so molecularly complex that current science does not allow for an exact copy to be made.

The Biotechnology Industry Organization (BIO) supports the Pathway for Biosimilars Act (H.R. 1548), which was introduced by US Reps. Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) in March and has more than 55 cosponsors. This bipartisan legislation lays out an effective, reasonable, and safe pathway to biosimilars and provides patients with the right balance between innovation and competition. This legislation requires clinical data while providing discretion for FDA to waive the requirement on a case-by-case basis. Immunogenicity data, which is necessary to avoid putting patients at risk of adverse effects from immune reactions, may only be waived after the issuance of product-specific guidance. The bill recognizes that switching products could put patients at risk of severe immunogenic responses and has high standards for interchangeability.

The Pathway for Biosimilars Act provides fair, responsible incentives for continued biomedical research that establish parity with the outcomes of the Hatch–Waxman regime developed for traditional pharmaceuticals. Innovator biologics would receive 12 years of data exclusivity (the period during which FDA could not rely on innovators' data to approve biosimilars) plus two additional years if the US Secretary of Health and Human Services approves a new indication that offers a significant clinical benefit and an additional six months for pediatric studies (if requested by the Secretary). This is consistent with the 13.5-year period during which the average traditional pharmaceutical is on the market without generic competition.

This period of data exclusivity is necessary for biotech companies to obtain a return on investment. The average biopharmaceutical takes more than $1.2 billion and longer than a decade of research and development and clinical trials. Unlike the traditional pharmaceutical industry, the biotech industry is made up primarily of small startups. These companies do not have products on the market and rely on an investment environment that provides incentives for the private sector to pursue this life-saving research.

Fast Facts: The Hatch–Waxman Act


The Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), which was introduced by US Reps. Henry Waxman (D-CA), Frank Pallone (D-NJ), and Nathan Deal (R-A), and its Senate companion (S. 726), introduced by US Senators Chuck Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), and Mel Martinez (R-FL), provide a far less balanced approach to biosimilars. Neither bill had attracted more than a handful of cosponsors as of mid-April.

H.R. 1427 shortcuts scientific requirements needed to ensure patient safety and creates an imbalanced system that could chill investment in research focused on discovering new treatments and cures for devastating diseases. The bill does not require clinical data or immunogenicity testing.

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

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.

Kathleen Jaeger

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.

In this case, however, our two industries principally disagree on the appropriate length of exclusivity. We believe that the proven successful Hatch–Waxman exclusivity model provides an appropriate length of exclusivity to ensure appropriate return on BIO's investment in innovation; allows for the appropriate incentive for the development of new treatments; and creates savings from generic-drug competition.

This model seems especially appropriate when one considers that there is a minimal difference (less than eight months) between the development of a biopharmaceutical product and the development of a traditional pharmaceutical product.

Accordingly, there is little justification for excessively expanding exclusivity beyond the Hatch–Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines. For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.

In November 2008, former House Ways and Means Committee Chief Economist and American Enterprise Institute Research Fellow Alex Brill released a white paper that demonstrated that BIO's argument for a long period of exclusivity is invalid. He argued that a period similar to Hatch–Waxman's five years of market exclusivity provides the necessary incentives to promote innovation in novel biologics while opening the doors for timely patient access to less costly biogenerics.

What policymakers and consumers should know is that market exclusivity protection is separate and distinct from the patent protection and corresponding patent extensions afforded to brand biopharmaceuticals today.

Yet, as BIO knows, market exclusivity acts as an absolute shield to their patents. Thus, from a practical perspective, considering the time it takes to develop a drug, extending market exclusivity beyond the Hatch–Waxman period would block the introduction of generic competition for nearly 20 years, derailing any potential cost savings to Americans and our healthcare system.

Kathleen Jaeger is president and CEO of the Generic Pharmaceutical Association, tel. 703.647.2480,