Samsung Bioepis has seen its SB12 proposed eculizumab biosimilar rival to Soliris endorsed by the EMA’s CHMP. At the same time, three generics also received positive CHMP opinions.
Samsung Bioepis has become the second firm to receive a positive opinion recommending granting a pan-European marketing authorization for a biosimilar rival to Soliris (eculizumab) from the Committee for Medicinal Products for Human Use within the European Medicines Agency, after the firm’s Epysqli version today received a positive opinion from the CHMP.
The European Commission typically acts within 67 days to convert CHMP positive opinions into marketing authorizations.
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.
