JOHNSON & Johnson has
petitioned the US Food and Drug
Administration (FDA) asking that
biosimilars be required to bear
similar, not identical, names to
those of their reference products.
The FDA is drafting regulations
for the approval of biosimilars and
J&J chief biotechnology officer Jay
Siegel said assigning similar, but
not identical, names would reflect
the legal and scientific reality that
biosimilars were similar but not the
same as their reference products,
Reuters reported.
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MONTU Group, its subsidiary Alternaleaf Pty Ltd, and their common director Christopher Strauch are facing legal action by the Therapeutic Goods Administration (TGA) in the Federal Court of Australia for alleged unlawful advertising on the effectiveness of their medicinal cannabis products.
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