Report
Damien Choplain ...
  • Martial Descoutures

Formycon AG : FYB202 approved by FDA

>Third product approved by FDA - FYB202/Otulfi (Stelara - J&J biosimilar) has obtained FDA approval in the subcutaneous and intravenous version for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and psoriatic arthritis, i.e. all Stelara indications. In 2023, Stelara posted sales of c. $ 11bn. FYB202 is the third product to be approved by the FDA that is derived from Formycon research after FBY201 (biosimilar of Lucentis and F...
Underlying
Formycon AG

Formycon AG is a Germany-based company engaged in providing biosimilar drugs and formulations. Its business activities are focused on the development and marketing of biopharmaceuticals that are similar to existing drugs, for which the patent protection is expiring. The Company focuses on treatments in the area of ophthalmology, immunology and other chronic diseases, covering all steps of biosimilar development process, from early-stage analysis of the originator drug to the preclinical and clinical testing phases, as well as the preparation of dossiers for marketing approval. Its biosimilar product pipeline consists of four candidates in pre-clinical and clinical testing phases, including FYB201, a biosimilar candidate for Lucentis; FYB202, a biosimilar candidate for Stelara; FYB203, a biosimilar candidate for Eylea, and FYB205.

Provider
Oddo BHF
Oddo BHF

​Oddo Securities provides securities brokerage and research services. The company offers equity, economic, and derivatives research and credit analysis services. It focuses on insurance, automotive, building materials, pharmaceuticals, telecommunications, information technology, and agri-food industries.

Analysts
Damien Choplain

Martial Descoutures

Other Reports on these Companies
Other Reports from Oddo BHF

ResearchPool Subscriptions

Get the most out of your insights

Get in touch