Draft guidance says unexpired pediatric exclusivity would continue to apply to a deemed 351(a) BLA on March 23, 2020, but industry says differences in how pediatric exclusivity operates under the statutory frameworks governing drugs and biologics could result in the loss of some marketing protection.

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.

Patient instructions for use of Mylan’s fluticasone/salmeterol generic are noticeably different from GSK’s reference listed drug but fall within the ‘different manufacturers’ exception to the ‘same labeling’ requirement.