Humira's 'Unique' Number Of Patents Makes Biosimilar Entry Risky, Pfizer Says
Pfizer wants to get its adalimumab biosimilar to market as soon as possible, but won’t say whether that’s before AbbVie's patents run out in 2023.
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But even with the legislative and regulatory changes proposed by the Biosimilars Forum, market share would still not reach levels seen in Europe, an analysis by Avalere finds.
Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.
Pfizer is the seventh company to enter licensing agreement with AbbVie; it has completed development program for its adalimumab candidate.