FDA To Hold A Two-Day Meeting On Biosimilars

As reported in Pharmalot blot, if you want to know what the FDA thinks about biosimilars and how to gauge immunogenecitiy or when bioequivalence studies will be needed? Then you may want to attend the two-day hearing the agency has scheduled on Nov. 2 and 3 at its Silver Spring, Maryland campus. Although not formally announced, a draft notice has been circulating for the past few days.

FDA To Hold A Two-Day Meeting On Biosimilars // Pharmalot.

This is seen as a signal that the agency is formulating a policy towards biosimilars in response to the go-ahead given by Congress in the health care reform bill. A key unanswered question surrounds testing standards the agency will require of drugmakers to ensure that biosimilars match brand-name treatments in both safety and efficacy.

A number of disparate constituencies are waiting for the answer to that question. I can hardly wait.

 

Posted by Bruce Lehr September 20th 2010.

 

Comments

[Ashritha (infoalcpl@gmail.com)]

My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
Various issues have been dealt with, such as:
- Patent expirations
- Regulatory frameworks
- Infrastructure Requirements
- Etc.
If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

[bigredbruce]

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