A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

With multiple Humira biosimilars slated for launch in the US next year, some simultaneously, a Vizient survey provides some insights into what could be the most important differentiating aspects. Generics Bulletin speaks to Steven Lucio, Vizient senior principal of pharmacy solutions, about the findings.

The US Association for Accessible Medicines’ annual report into generic and biosimilar savings has documented another year of increased cost savings thanks to off-patent drugs, but says some patients are still overpaying for their generic medicines. 

The final shortlist of contenders has been unveiled for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt on 2 November.

Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.

Formycon has revealed that pembrolizumab is one of its six biosimilars in development. The blockbuster reference biologic Keytruda brought in $17.2bn for Merck & Co. in 2021.

Having previously identified itself as the frontrunner in the race to launch a biosimilar to Amgen’s Prolia, Sandoz has now delivered positive confirmatory data, shortly after being sued in the US over its Polpharma-partnered proposed Tysabri biosimilar.

Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.