Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.
Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.
The approval was based on a review of the data that confirmed the infliximab biosimilar was equivalent to the reference product in terms of safety and efficacy. The data included a phase 3 confirmatory study in rheumatoid arthritis, REFLECTIONS B537-02. The study met its primary endpoint of achieving the American College of Rheumatology’s criteria for a 20% improvement (ACR20) response at week 14.
On the strength of the trial results, the biosimilar was authorized for use in all indications of the reference medicine: rheumatoid arthritis, adult Crohn’s disease, pediatric Crohn’s disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
“Biosimilars, such as Zessly, help to address a significant unmet need for earlier patient access to biologic medicines and are at the heart of our Sandoz commitment to improving and extending lives,” said Richard Francis, CEO of Sandoz, in a statement.
Sandoz currently has 3 other biosimilars at various stages of development within its pipeline, including:
Zessly’s EC approval makes it the third biosimilar from Sandoz in the past 12 months to be approved, and the sixth approved biosimilar for the company overall.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Biosimilars Rheumatology Roundup for April 2023—Podcast Edition
April 30th 2023On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.
Fylnetra Launches in the United States
May 16th 2023Amneal Pharmaceuticals has announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.
Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing
May 15th 2023Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.
2 Clarke Drive
Cranbury, NJ 08512