Regional US biotech association and business urge support for Biosimilars Bill in Congress

In the USA, a coalition of New England business leaders have joined the New England Biotech Association (NEBA) to push for Congress to approve a legislative pathway for biosimilars that protect patient safety but also provide sufficient incentives for new innovative products to be developed. The announcement follows confirmation at the recent annual meeting of the nation's generic drugmakers, the GPhA (see September 22 Pharma Letter story), that US President Barack Obama favors seven years of market exclusivity for biosimilars.

The NEBA and 27 other organizations and biotechnology leaders across New England said in a letter to all members of the region's congressional delegation that the biosimilars legislation is the single biggest issue in protecting the future viability and growth of New England's biotechnology industry: "New biologic medicines represent the greatest hope for treating diseases such as cancer, asthma, Parkinson's and Alzheimer's. It is crucial that biosimilars legislation preserve the incentives necessary for biotech researchers to develop the next breakthrough medical treatments. These incentives should include an appropriate period of 12-years of data exclusivity to allow New England's biotech companies to attract and protect the massive investment necessary to develop a biologic," the trade group stresses.

During its recent consideration of health care reform legislation, both the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee adopted bipartisan amendments that provide a safe, effective and reasonable pathway for the approval of biosimilars. These amendments, approved by overwhelmingly bipartisan votes, strike the right balance between expanding competition to lower costs for consumers and preserving incentives for continued biomedical innovation by providing a 12-year period of data exclusivity, the NEBA argues.

If the final legislation approved by Congress does not protect patient safety and provide sufficient incentives for investment in innovative new biologic medicines, it would deliver a devastating blow to the hope held by millions of patients and seriously undermine the region's biotech sector," it says.
As the regional policy and public affairs voice for the biotechnology and biopharmaceutical community, the NEBA represents state biotech associations, companies, academic institutions and other organizations from all six New England states - Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont.