Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.
A 505(b)(2)-like pathway for biosimilars could make the agenda for upcoming US Food and Drug Administration bills, given its potential to streamline approval of some products and encourage innovation.
The generics pathway allows the applicant to rely on some data that others developed to gain approval. Sponsors can improve...
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Sandoz snatched commercialization rights to Lupin’s ranibizumab biosimilar across multiple global markets, while also taking steps to decarbonize its operations in Europe.
Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.
Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.
Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.
Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.
