Progress Made on the Path to Biosimilars

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-10-02-2009, Volume 33, Issue 10

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.

The American Cancer Society estimates that 1.5 million Americans will be diagnosed with cancer in 2009, and according to the American Diabetes Association, one in 12 Americans has diabetes. These individuals and the countless others who fight chronic diseases every day have the most to win or lose in the national healthcare reform debate. As the debate continues, Congress must bear in mind its responsibility to help patients of today—and tomorrow.

Jim Greenwood

Many patients look to biologics, cutting-edge medicines developed through biotechnology, to improve their quality of life and give them hope for the future. Biologics are highly sophisticated medicines made in living systems such as animal, plant, or bacterial cells. Patients suffering from previously untreatable conditions such as diabetes, ALS, and HIV/AIDS have had their lives improved and extended by biologics. Future biotech advances hold promise for new therapies and possibly cures for diseases such as cancer, Parkinson's, Alzheimer's, and many rare diseases.

As part of healthcare reform, Congress is currently considering giving the US Food and Drug Administration authority to approve biosimilars which are similar to, but not the same as, innovator biologics. The Biotechnology Industry Organization (BIO) is a leading advocate for the creation of a pathway for the approval of biosimilars, which will lower costs through increased competition, expand access to life-saving medicines, protect patient safety, and promote further biomedical innovation.


Biosimilars are not like generic pharmaceuticals, which are exact copies of chemical drugs typically made by mixing together well-defined chemicals following the formulas and predictable rules of organic chemistry. The same final product of a chemical drug can sometimes be obtained through a very different process, and the product can be analyzed in a laboratory to confirm that it is exactly what it is supposed to be.


Biologics are vastly more complex than traditional pharmaceuticals, and producing an exact duplicate is not possible with today's science, as the FDA has recognized. Because of their complexity, even slight changes in the manufacturing of biologics can cause undetected changes in the biological composition of the product. These changes can affect the safety and effectiveness of the product in patients so the approval of biosimilars must be based on the same rigorous standards of safety, purity and potency the FDA applies to pioneering biotechnology therapies.

Much of the debate surrounding biosimilars has centered around the appropriate period of data exclusivity. During that period, biologics developers would have exclusive rights to their proprietary safety and efficacy data before FDA could use it to approve a competitor's product. Setting too brief a period will undermine the incentives needed to attract funding for continued research and development. BIO believes a minimum of 12–14 years of data exclusivity is required to set the right balance between expanding competition and preserving incentives for continued biomedical breakthroughs.

Claims by the generic drug industry that 12–14 years of data exclusivity would guarantee a monopoly for biotech companies are flat-out wrong. Even within that period, an innovator biologic could face competition from other companies which conduct their own clinical trials, as is currently the case with biotech therapies such as insulin and those to treat rheumatoid arthritis.

A period of 12–14 years would establish parity with the Hatch-Waxman paradigm for pharmaceuticals, which provides patent term restoration for up to 14 years. On average, pharmaceuticals are marketed in the United States for 13.5 years before facing generic competition. A biosimilars pathway can provide the same degree of effective market protection through data exclusivity.

Fortunately, Congress appears to be heading in the right direction to establish a fair and reasonable pathway for biosimilars. In July, committees in both the House and Senate incorporated biosimilars provisions in healthcare reform bills.

The Senate Health, Education, Labor, and Pensions (HELP) Committee approved a bipartisan biosimilars amendment by a vote of 16 to 7 that includes 12 years of data exclusivity. The Committee defeated another amendment which would have provided only seven years of data exclusivity.

The House Energy and Commerce Committee adopted a biosimilars amendment to healthcare reform legislation by an overwhelming vote of 47 to 11. The amendment was based on the Pathways for Biosimilars Act (H.R. 1548) and the Senate HELP Committee amendment. It provides 12 years of data exclusivity plus an additional six months for pediatric studies.

A wide array of stakeholders joined BIO in supporting the two successful amendments. The American Autoimmune Related Diseases Association, Association of American Universities, National Venture Capital Association, and RetireSafe were among the many stakeholders to publicly express their support of both amendments. Many more groups—from labor unions to patient groups to governors—have indicated their support for a significant period of data exclusivity.

The amendments in both Congressional Committees received strong, bipartisan support which bodes well for floor votes. In addition, the Pathways for Biosimilars Act would provide 12 years of data exclusivity and has 142 cosponsors. The competing bill, H.R. 1427, which would provide 0–5 years of data exclusivity, has only 14 cosponsors.

This solid bipartisan support from legislators on the two Committees and the 142 cosponsors of the Pathway for Biosimilars Act for 12 years of data exclusivity is critical. The vast majority of biotechnology companies throughout the country are small firms without products on the market. They rely on venture capital for the long and expensive process of research, development and clinical testing. Without assurances of a return on investment, investors will put their funds in less risky endeavors. This could undermine the ability of the biotech industry to use our knowledge of DNA to drastically improve human health and reduce human suffering.

While many aspects of healthcare reform are still being debated, a fair and reasonable pathway for biosimilars has strong support in both Chambers and among both parties. The right pathway for approving biosimilars will balance our shared desire to expand access to lifesaving medicines with the imperative to protect patient safety and promote further biomedical innovation. Striking this balance is critical for the patients of today—and tomorrow.

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