Viatris has voluntarily recalled one batch of its Semglee (insulin glargine) pre-filled pens due to the potential for the label to be missing on some pre-filled pens within a labelled carton. The company said that it will arrange for the return of all recalled products. 

Teva CEO Kåre Schultz has weighed in on Novartis’ plans to conduct a strategic review for its Sandoz unit, while also airing frustrations over continued delays for complex products in the US.

Viatris and partner Biocon have suffered a setback over their proposed insulin aspart biosimilar rival to NovoLog in the US, after the FDA issued a CRL relating to the filing.

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

Generic competition to Vasostrict is nearing in the US after the FDA confirmed Eagle’s previously unresolved potential for 180-day market exclusivity.

India authorizes molnupiravir for restricted emergency use in COVID-19, marking the arrival of around a dozen “affordable” generics of  Merck & Co. and Ridgeback Biotherapeutics' oral antiviral. Physicians say data are “pretty compelling” notwithstanding the narrow FDA nod.

Optional checklists will help ensure submissions have all the required information.

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.

Sandoz and EirGenix have followed their US filing for a biosimilar rival to Herceptin with a European filing for the EG12014 trastuzumab candidate.