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Regulation

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Viatris Recalls Semglee Batch Citing Missing Labels

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. 

Biosimilars Regulation

Teva Comments On Sandoz Implications Amid Strategic Review

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.

Market Intelligence Commercial

Biocon And Viatris Get CRL From FDA On Insulin Aspart

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.

Biosimilars United States

Is CREATES Act Equipped To Handle Biosimilar Complaints?

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.

Biosimilars Legal Issues

Eagle Bags Vasopressin Exclusivity And Details Launch Plans

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

Regulation FDA

Wave Of Molnupiravir Generics In India Amid Early Physician Cheer

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.

Approvals Coronavirus COVID-19

ANDA Sponsors Given More Paperwork

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

Generic Drugs Review Pathway

US FDA Hoping To Spur More ANDA Pre-Submission Meetings During GDUFA III

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.

Generic Drugs User Fees

Sandoz EMA Trastuzumab Application Follows US Filing

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

Biosimilars Europe
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