BioBlast®

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

The FDA extended the indications of Simponi Aria® (golimumab) to include fatigue in patients with psoriatic arthritis and rheumatoid arthritis. This is the first TNF inhibitor approved to include fatigue improvement in its labeling.

Docwirenews reports a new post-approval safety surveillance study of Janssen’s golimumab Simponi® demonstrated that there is no association between exposure to golimumab and an increased risk of prespecified outcomes.

Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.

Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.

Ankylosing Spondylitis News reports new data from Germany indicates Simponi® (golimumab) is an effective therapy for people with ankylosing spondylitis and other chronic inflammatory conditions, regardless of pre-treatment with other TNF inhibitors.

J&J announces it has filed two supplemental marketing applications for Simponi Aria (golimumab) with the FDA. J&J have applied for the additional indications of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients at least two years old.

Bio-Thera announces commencement of Ph I trials of proposed golimumab biosimilar.