Biotech leader Can-Fite BioPharma, known for its advances in oncology, inflammatory, and liver diseases, has taken a significant step forward with its announcement today of the submission of a pediatric study plan to the U.S. Food and Drug Administration (FDA). This ambitious move is for the treatment of adolescents with psoriasis using their proprietary drug […]
Biocon Ltd. said that its subsidiary Biocon Biologics has signed an out-licensing agreement with Japanese pharma company Yoshindo Inc. for commercializing a couple of its pipeline biosimilar assets — bDenosumab and bUstekinumab in Japan. Ustekinumab is a biosimilar of the reference drug Stelara, which is a monoclonal antibody for the treatment of psoriasis, ulcerative colitis, […]
Lupin Limited has secured approval from Health Canada for Rymti, the company’s biosimilar to Enbrel (etanercept), an inhibitor of tumour necrosis factor (TNF). Rymti is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis. Lupin said that Rymti is available in Canada as an […]
Strides Pharma Science said that its stepdown fully-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured approval from the US Food and Drug Administration (USFDA) for Cyclosporine Softgel Capsules USP (Modified), 25 mg, 50 mg, and 100 mg. The immunosuppressant medication product is bioequivalent and therapeutically equivalent to Neoral Capsules 25 mg, 50 mg, […]
Glenmark Pharmaceuticals has secured tentative approval from the US Food and Drug Administration (FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%. The product is the generic version of Enstilar Foam, 0.005%|0.064%, a psoriasis medication from Leo Pharma. For the 12-month period ending March 2022, the Enstilar Foam, 0.005%|0.064% market achieved annual sales of around $115.2 […]
Mylan has officially launched Hulio, its biosimilar to AbbVie’s Humira (adalimumab), across major European markets. This launch follows the European Commission’s recent approval of Hulio for all indications of the reference product. Hulio will be accessible to patients in Europe as soon as possible, thanks to a partnership between Mylan and Fujifilm Kyowa Kirin Biologics. […]
German pharmaceutical giant Boehringer Ingelheim has announced a significant milestone in the treatment of moderate-to-severe chronic plaque psoriasis. Their drug, Cyltezo, a biosimilar to AbbVie’s renowned psoriasis medication Humira (Adalimumab), has demonstrated clinical equivalence in a pivotal phase 3 trial, known as NCT 02850965. The trial successfully met its primary endpoint, which was the proportion […]