Hospira Biosimilars Policy Positions
As the first American company to provide biosimilars in Europe and Australia, Hospira has been at the forefront of driving global policies to support the availability of biosimilars. Currently, Hospira is working to ensure that regulations and policies in the United States support the introduction and successful adoption of biosimilar drugs by mid-decade.
Successful adoption of biosimilars in the United States will result in significant savings for U.S. patients and the broader healthcare system. Hospira endorses the Biologics Price Competition and Innovation (BPCI) Act, passed in March 2010 as part of the Affordable Care Act, which created an abbreviated licensing pathway for biosimilars of U.S.-licensed reference products. This is the initial framework for bringing biosimilar products to U.S. consumers. In February 2012, the FDA issued guidelines for industry regarding implementation of the BPCI Act approval process. These guidelines outline the fundamental principle that biosimilars must demonstrate high similarity to their originator molecules, in both the laboratory and the clinic.
Why extrapolation is paramount to achieving the full potential of biosimilars
Science advances by the accumulation of knowledge, with each generation of understanding building on the last. Just as in everyday life, there’s no need to repeat experiments to re-learn basic facts. We know that DNA is a double helix, that water at sea level boils at 100 degrees Celsius, and that the earth goes around the sun. There is no need to re-prove any of these basic facts any more than there is a need to relearn multiplication tables from kindergarten as part of a college math course. To do so would be needless and duplicative.
The same principle applies in medicine. Physicians have come to know and trust biologic medicines for cancer, inflammatory disease, and a range of other serious illnesses. These medicines have been proven to work over and over. To require that they be re-tested would be as needless as re-learning the multiplication table or re-proving gravity. This is a basic tenet behind the proven principle of extrapolation, which allows manufacturers of biosimilars to make biologic drugs more affordable as they do not have to build into the cost of each dose the billions of dollars it takes to develop a the new original drug. Importantly, those savings are passed along to patients. There have been 21 successful introductions of biosimilars in the EU thus far, with the EMA allowing extrapolation of these drugs for other indications once comparability has been sufficiently established. The policy paper below authored by Sumant Ramachanda, M.D., Ph.D., senior vice president and chief scientific officer; Stan Bukofzer, M.D., Chief Medical Officer; and Lisa Skeens, Ph.D., Corporate Vice President, Global Regulatory Affairs, Hospira, explains why extrapolation is paramount to achieving the full promise of biosimilars.
- “Why Extrapolation is Paramount to Achieving the Full Promise of Biosimilars” - Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira
The Value of Government and Stakeholder Education
Educating government leaders and stakeholders creates more informed public policy, better regulation and increased industry standards. Hospira works with government, others in our industry, the broader business community and civil society to advocate for public policies that support our business goals. We believe that education and engagement with government agencies and stakeholders results in more informed public policies and greater industry awareness of issues related to Hospira’s goals. To that end, Hospira is engaged with governments and major stakeholders in the United States and around the world, resulting in stronger, more informed public policies in numerous countries. These efforts are guided by Hospira’s commitment to going beyond basic regulatory compliance and implementing the highest standards of corporate accountability, transparency, integrity and responsibility.