Hospira Biosimilars Policy Positions

Policy Positions ImageAs 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.

What's in a Name? For Biosimilars, A Lot

Biosimilars have the potential to bring cost savings and greater accessibility to important biologic medicines for U.S. patients. However the regulatory landscape for U.S. biosimilar products is still evolving. Industry leaders are pushing to avoid policies and regulations that set up barriers against biosimilar adoption and cost savings.

Yet we are concerned that a seemingly innocuous matter – how biosimilars are named – could put such barriers in place. The policy paper below authored by Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira, stresses how important it is that biosimilar drugs receive the same non-proprietary names as their reference biologic products.

Such a system will prevent confusion among clinicians and patients, boost accessibility to more affordable, accessible and just-as-effective biosimilar therapies and is in line with the practice followed for more than 40 years with the "small molecule" generic drugs that millions of people around the world rely on.

Policy Positions Image_thumbnail View the paper here:


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.