Regulatory Roundup: FDA to Hold Public Hearing on Biosimilars Legislation, And More.

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ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA to Hold Public Hearing on Biosimilars Legislation, And More.

FDA will hold a two-day public hearing Nov. 2–3, 2010, in Silver Spring, Maryland, on the implementation of the Biologics Price Competition and Innovation Act of 2009, part of the healthcare reform legislation signed by President Obama last year. The Act “would establish an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed biological product,” according to an FDA news release about the meeting. The hearing is meant to obtain feedback on the Act’s implementation, especially regarding any potential scientific and technical challenges associated with the larger molecular structure and manufacturing of biological products, says the notice.

FDA also has announced nearly $3 million in grants for tuberculosis (TB) research as part of its Critical Path initiatives. The grants are supporting six research projects aimed at the diagnosis, treatment, and prevention of TB, which “remains a major public health challenge with an increasing prevalence worldwide,” according to the agency's announcement. Two recent articles published by FDA’s Office of Critical Path Programs note that “advances are urgently needed in TB drug development to shorten therapy and to treat drug-resistant disease.” The grantees are listed on the FDA website.



Rx-360, the international pharmaceutical supply-chain consortium, has elected a new board of directors. The new leadership will begin their terms on Jan. 1, 2011. Taking over the chairmanship, which has been held by Martin Van Trieste of Amgen, will be Lynne Byers of GlaxoSmithKline. Vice-chair will be Al Kentrup of Pfizer. A full list of board members and their representative bio/pharmaceutical companies are listed on the Rx-360 website.


This week, in Bethesda, Maryland, ISPE and PDA will co-host a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. The workshop will feature members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and include breakout sessions on design space, control strategy, quality system, and risk management. Industry is encouraged to attend and PharmTech will be blogging from the event at