FDA Guides On Adding Biosimilar Indications
Agency Proposes Streamlined Pathway For Biosimilar Indication Carve-Ins
Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.
You may also be interested in...
The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.
Biosimilar Information Wars: Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake In The US
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.