Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.
Newly public Alvotech says it anticipates being “launch ready” by the firm’s expected US launch on 1 July 2023 for its proposed AVT02 biosimilar to Humira (adalimumab), despite a US Food and Drug Administration complete response letter noting certain deficiencies related to Alvotech’s manufacturing facility in Reykjavik, Iceland.
“Satisfactory resolution of the deficiencies is required before the FDA may approve this biologics license application,” Alvotech noted, with the agency’s findings
Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.
As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.
With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.
Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.
As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.
With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.
As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.
