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

Ref: Sandoz| Image: Vilaggazdasag