Biotech Values

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Isn't there a conference coming up in November on the subject?

Yes, Nov. 2-3.

Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting

The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.

Date(s): November 2-3, 2010

Time: 8:30 a.m. to 4:30 p.m.

Location: FDA White Oak Campus
10903 New Hampshire Ave, Building 31, Room 1503
Silver Spring, Maryland 20993

http://www.fda.gov/Drugs/NewsEvents/ucm221688.htm

In addition, EU to spell out requirements for copies of antibody drugs next month (Nov).

(Reuters) - European regulators will spell out requirements for copies of antibody drugs next month, paving the way for generic competition in a multibillion-dollar market that includes treatments for cancer and immune system disorders.

European Medicines Agency (EMA) Executive Director Thomas Lonngren told Reuters on Friday that guidelines on biosimilar monoclonal antibodies would be published after being reviewed by the agency's expert committee on drug approvals in November.

The keenly awaited guidelines will then be open for three to six months of external consultation before being formally adopted, most likely in the second half of 2011, he said.

http://www.reuters.com/article/idUSTRE69047620101001