US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

Teva is keeping a keen eye out for opportunities like its US biosimilars agreement with Alvotech and more recent deal with Bioeq for biosimilar Lucentis as it attempts to maintain revenues in the coming years, following a cut to full-year sales guidance for 2021.

Off-patent industry players from around the globe now have an extra week to submit their achievements to the Global Generics & Biosimilars Awards 2021 being held on 10 November, after the entry deadline was extended by a week to 6 August. Pharmacloud has also joined the event, sponsoring the Leader of the Year category.

Advanz Pharma has immediately hit back at a decision announced by the UK’s competition regulator to impose fines of more than £100m over the firm’s historical pricing of liothyronine tablets.

A US district court has denied Zydus Cadila’s motion for summary judgment on Sherman Act antitrust counterclaims against Takeda over a branded formulation of lansoprazole, finding that the originator did have basis to sue the ANDA sponsor again in 2018.

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

IGBA chair Sudarshan Jain has indicated that "companies are undergoing the change towards digital health," in the second part of an exclusive interview with Generics Bulletin in which Jain and IGBA secretary general Suzette Kox talk about the pandemic-driven shift towards digitalization and computerization.

The AAM’s latest study reveals that the Medicare Part D program continues to underperform compared to commercial plans in providing patients with access to generic medicines. The industry association has also urged policymakers to modernize Medicare Part D.

Advanz has claimed a first with a European launch of a rival to Ipsen’s Somatuline, introducing its generic lanreotide in Germany under the name Mytolac.