Tags : Autoimmune Diseases

Biosimilars

Alvotech and DKSH Extend their Collaboration to Commercialize Six Biosimilars

Shot:   The companies expand their strategic partnership to commercialize six new biosimilar product candidates for the Asian markets In Mar’2020, the companies collaborated for AVT02 (biosimilar, adalimumab). The collaboration targets Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh, and Pakistan The expansion deepens the partnership b/w the two companies […]Read More

Biosimilars Regulatory

Innovent’s Sulinno (biosimilar, adalimumab) Receives NMPA’s Approval for Autoimmune Diseases

Shots: The NMPA has approved Sulinno for the treatment of RA, AS, and psoriasis in China. The approval of the Sulinno marks the expansion of Innovent’s portfolio in the non-oncology field Sulinno has similar clinical efficacy and safety to its reference product, Humira. The launch will provide Chinese patients with affordable adalimumab, bringing hope and […]Read More

Biosimilars

Pfizer’s Ruxience (biosimilar, rituximab) Receives CHMP’s Positive Opinion for Cancer

Shots: The EMA’s CHMP has adopted a positive opinion, recommending MAA for Ruxience, a biosimilar referencing MabThera The regulatory submission is based on REFLECTIONS B3281006 study assessing the efficacy, safety, immunogenicity, PK/PD of Ruxience demonstrating biosimilarity to the reference product in patients with CD20+, low tumor burden FL Ruxience is a mAb indicated for the […]Read More

Biotech

Astellas Signs an Exclusive License Agreement with Pandion to Deliver

Shots: Pandion to receive up to $45M as upfront and payments for research and preclinical activities, ~$750M as development and commercial milestone and royalties on global sales of the therapies developed via collaboration Pandion to be responsible for drug designing and discovery of bispecific therapies utilizing its modular immune effector and tissue tether platform while […]Read More

Biosimilars

Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune

Shots: The FDA’s approval is based on P-III clinical study assessing Hadlima vs reference product, Humira (adalimumab) in 544 patients in a ratio (1:1) with moderate to severe rheumatoid arthritis despite methotrexate therapy The P-III clinical study resulted in biosimilarity data of Hadlima to the reference product Humira, i.e, @24 wks. ACR20 (72.4% vs 72.2%). […]Read More

Biosimilars

Pfizer’s Ruxience (biosimilar, rituximab) Receives FDA’s Approval for Cancer and

Shots: The approval is based on REFLECTIONS B3281006 study results assessing Ruxience vs reference product, Rituxan (rituximab) in patients with CD20-positive, low tumor burden follicular lymphoma The REFLECTIONS B3281006 study results demonstrated biosimilarity data of Ruxience to the reference product. Ruxience is the third biosimilar of Pfizer’s oncology portfolio to be approved in the US […]Read More