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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.
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