Biosimilar Sponsors Offer Advisory Committee Primer
Extrapolation, uncertainty could prove important when the Oncologic Drugs Advisory Committee considers Sandoz’s filgrastim biosimilar on Jan. 7.
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Physicians appear more willing to prescribe Hospira’s Inflectra, a biosimilar version of J&J’s Remicade, to new patients in countries in Europe where it is available, but less inclined to switch patients already taking the brand. The company’s experience in Europe could offer lessons for manufacturers looking to bring biosimilars to market in the US.
Biosimilar products are not intended to be stand-alone development programs, agency stresses, noting that early analytical data can allow for more targeted clinical trials later.
An FDA blog post says some inspections have been hindered and application assessments soon could be delayed by the EU General Data Protection Regulation (GDPR), but experts argue the law includes directions to allow data sharing and remain compliant.