Sandoz’s Hymiroz (adalimumab-adaz) Receives the US FDA Approval for Treatment of Chronic Autoimmune Diseases
Shots:
- The approval is based on the non-inferiority data demonstrating its biosimilarity in terms of PK, immunogenicity and safety meeting all 1Eps & results of ADACCESS study confirming its safety & efficacy with referred biologic
- Hymiroz’s (a TNFi) approval is third FDA approval for Sandoz which is indicated to treat RA, JIA in patients ≥4 yrs. of age, PsA, AS, adult CD, UC and plaque psoriasis (Ps)
- On 11 Oct, 2018 Sandoz resolved all global IPR litigations with AbbVie regarding adalimumab biosimilar and is expected for sales on 23 Sep, 2023 in the US
Click here to read full press release/ article | Ref: Sandoz| Image: Vilaggazdasag