International Biosimilar Market Updates

Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe

On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first biosimilar product KAULIV received a positive recommendation from European Medicines Agency (EMA) for granting market authorization.  KAULIV is a biosimilar referencing FORTEO, a recombinant human teriparatide injection indicated for men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures.


Alvotech and Cipla’s HUMIRA Biosimilar Approved in Australia

On November 14, Alvotech announced that the Therapeutic Goods Administration of Australia granted marketing authorization to Cipla Australia Pty Ltd (Cipla) for Alvotech’s AVT02, a high-concentration low-volume biosimilar to HUMIRA (adalimumab).  In Australia, AVT02 will be marketed as CIPTUNEC and ARDALICIP and indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults and children (≥ 6 years; weighing ≥ 40 kg), ulcerative colitis, psoriasis in adults and children, hidradenitis suppurativa in adults and adolescents (from 12 years of age) and uveitis.  CIPTUNEC/ARDALICIP is the first approved biosimilar from an exclusive commercialization partnership between Alvotech and Cipla.  The same biosimilar has been approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland as HUKYNDRA; and in Canada and Saudi Arabia as SIMLANDI.