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Are You at the Table, or On the Menu? Shouldn’t That Be an Easy Choice?

The annual meeting of AAM, Access 2019, is being held in the Hyatt Regency, New Orleans from February 4-6, 2019. The agenda of February 4th involved several sessions to be attended only by the members, including that of Science & Regulatory and Policy Working Group, and the Board Meeting.  The Science & Regulatory Team discussed about the future of GDUFA and BSUFA, while the Board elected new members.  Robert Stewart of Amneal was elected to Chair the AAM Board, Alok Sonig of Lupin was elected as the Vice Chair, and Carol Lynch of Sandoz ws elected as the Secretary Treasurer.

The February 5th agenda involved a lot of interesting discussions.  After the welcome and introduction by Nancy Snyderman, former NBC News Chief Medical Officer, Chester “Chip” Davis Jr., President and CEO of AAM gave the State of AAM address.  This was followed by several group discussions regarding various aspects of generic and biosimilar industry, including an outline of the barriers to approvals, fair pricing, supply chain related challenges, trends related to Global versus US generics, as well as others.

The discussions were lively and relevant and struck a chord with the audience. The barriers to biosimilar market entry, which include potential clinical issues that appear to relate to negative publicity and misinformation, as well as economic and patent issues, were outlined and hold particular significance given that while 17 biosimilars have been approved, only 5 are currently on the market.

A topic that came up like a poetic refrain, concerned the disparity of ANDA approvals versus launch of the approved generics, and the factors driving it. IQVIA data presented by Doug Long showed that while over 50% of ANDAs approved were not immediately launched, that percentage dropped to just about 40% after a year or so.

There was also discussion related to the continued downward pressure on generic pricing which adversely affects the generic industry. Participants noted that any kind of price increase, irrespective of whether it is for a generic product or innovator product, and no matter how small and justified, has been an easy target of criticism.

Chip Davis stressed that the generic industry needs to be proactive in being heard. “In Washington, if you are not at the table, you are on the menu”.  It is high time for generics and the biosimilar industry to be at the table.

The first two days of the conference were interesting and brought up many issues which may lay the foundation for future lobbying efforts, as well as negotiations for GDUFA III and BSUFA III.