On October 22, 2024, Alvotech and Teva announced that SELARSDI™ (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. We previously reported that SELARSDI™ was approved by the FDA for 45 mg/0.5 mL and 90 mg/mL in a single-dose…
On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s PROLIA® (denosumab) that treats osteoporosis. Both applications include all indications approved for PROLIA®, including conditions…
On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further strengthening the pair’s alliance announced earlier in April of this year. For mAbxience, “this second collaboration is a testament to…
On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™ (ustekinumab-aauz), a biosimilar to STELARA®. FYB202/OTULFI™ is an interleukin-12 and interleukin-23 antibody and was approved for moderately to severely active Crohn’s disease,…
On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product” classification. See Eli Lilly & Co. v. Becerra et al., No. 1:24-cv-01503 (S.D. Ind.). Lilly argues…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active…
On May 20, 2024, Teva Pharmaceuticals (“Teva”) and Alvotech announced the availability of SIMLANDI (adalimumab-ryvk) injection in the United States, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis….
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). The product was approved as a subcutaneous injection for the treatment of adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and for active psoriatic…
On April 1, 2024, the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and remanding to the district court to reevaluate its obviousness decision. The Federal Circuit’s analysis provides…
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. As part…