Tuesday, August 31, 2010

Biologics lead to tricky regulation ground

The Lawyers Weekly looks at the legal problems that will arise as a result of the pathway that is now built from biosimilars. There is anticipated legal battles that legal battles will rage due to lack of regulation in the industry. Currently, biosimilars aren't required to have clinical trials, but they are not exact molecular duplicates like generic drugs. There are currently many discussions happening over whether or not biosimilars should have to undergo clinical trials. Our LinkedIn Group is currently debating this topic. Join the Business of Biosimilars LinkedIn group and find out what our members have to say about whether or not biosimilars should be required to go through clinical trials.

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