Abiraterone has a development history involving several organizations, and the terms developer, originator, manufacturer, brand owner and marketing authorization holder should not be treated as interchangeable.
Early development
Research into androgen synthesis inhibition originated at the Institute of Cancer Research. The development program subsequently involved Cougar Biotechnology, which developed abiraterone acetate for prostate cancer.
Reference product
Zytiga is the established reference product containing abiraterone acetate. In the European Union, the EMA identifies Janssen-Cilag International N.V. as the marketing authorization holder for Zytiga.
Generic manufacturers
Authorized generic products can be manufactured and marketed by companies unrelated to the original developer. EMA records, for example, identify different marketing authorization holders for generic abiraterone products.
Specific website product
The company manufacturing the particular Abiraterone 250 mg product represented on this website is:
It should be verified from the product packaging, regulatory record and official manufacturer documentation.
Why this distinction matters
A company can:
- Discover a medicine.
- Develop the reference product.
- Own a brand.
- Hold a marketing authorization.
- Manufacture a product.
- Distribute a product.
These roles can involve different legal entities.