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The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
Amgen is taking Novartis’s biosimilar division to court over alleged patent infringement for seeking FDA approval to produce a generic version of its blockbuster drug Enbrel. Read More
Drugmakers producing hormones should consult with the FDA before seeking to opt out of an environmental assessment because of the impact of those drugs on the water supply. Read More
The Senate HELP Committee’s second of three markups is scheduled for March 9 to examine several pieces of legislation as part of the Senate’s piecemeal version of the House’s 21st Century Cures Act. Read More