Repeal of Healthcare Reform Threatens to Dead-End the Biosimilars Pathway
Recent moves by Congress to repeal the healthcare reform act of 2010 (Patient Protection and Affordable Care Act [PPACA]) threaten to wipe out a pathway for the introduction of biosimilars in the US (Biologics Price Competition and Innovation Act [BPCIA]).
Most of the discussion regarding repeal of this legislation has centered around the impact on the national deficit and patient access to affordable care with little mention of its effect on biosimilars. While not necessarily the best compromise between incentivizing and protecting innovators and encouraging those developing biosimilar versions of innovator drugs, we were encouraged that the BPCIA provided a pathway for the introduction of biosimilars in the US similar to the pathway already in place in Europe and several other countries. According to the Congressional Budget Office the PPACA will result in significant reduction of the deficit while its repeal will increase the deficit by as much of $230 billion by 2021 from canceled cuts in federal spending on health care, especially for Medicare, roll back of scheduled tax increases and fees, and increased costs of biopharmaceuticals.
Clearly the introduction of biosimilars could provide potential savings of tens of billions of dollars to patients over the next decade but these benefits are being overlooked in the midst of the political controversy over affordable healthcare and its potential price tag. Without BPCIA, access to affordable biosimilars in the US is severely jeopardized, putting US patients at a distinct disadvantage compared to their European counterparts. In fact, while the debate over biosimilars continues in the US, EMA continues to move forward in enabling biosimilars development and recently issued a draft guidance for the development of biosimilars monoclonal antibodies.
While we do not believe that Congress will ultimately repeal the entire health care reform law, the ongoing debate may hinder the finalization of a biosimilars pathway and slow introduction of biosimilars in the US. As part of any eventual revision to the legislation, we would welcome changes in patent certification disclosures, clarification on additional periods of exclusivity for product modifications, and consideration of non-US reference product data that do not make the hurdle for biosimilars development so onerous as to discourage their development. To ensure a competitive biosimilar marketplace with expanded access to lower cost biologics for all patients, Congress must maintain some version of the legislative pathway contained in the BPCIA and FDA must implement clear, reasonable guidelines and regulations for the development and approval of biosimilars.
As Congress debates changes to the PPACA and BPCIA, we would welcome changes in patent certification disclosures, clarification on additional periods of exclusivity for product modifications, and consideration of non-US reference product data in order to lessen the hurdle for biosimilars development. However, it is clear to us that if the US is to have a competitive biosimilar marketplace that expands access to lower cost biologics for all patients, Congress must retain its commitment to biosimilars embodied in the BPCIA and FDA must implement clear, reasonable guidelines and regulations for the development and approval of biosimilars.