The Centre for Biosimilars reported on a study on Celltrion’s CT-39 (biosimilar omalizumab) presented at the American Academy of Allergy Asthma and Immunology annual meeting. Celltrion reported that the study demonstrated equivalence with Xolair® (omalizumab).
Evio Pharmacy announced a roll-out of a biosimilar strategy to help make medicines affordable. Evio announced that it has contracted directly with biosimilars manufacturers for autoimmune disease and cancer therapeutics.
OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar Solutions Inc. to create a contract biosimilars development/manufacturing organisation (including process development, plasmid, vectors, cell banks, processing and testing f...
03 Mar 22 | US | FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable biolo...
Samsung Bioepis and Biogen announced that Health Canada approved Byooviz™ (biosimilar ranibizumab) on 8 March for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to ret...
As a female led boutique firm, Pearce IP celebrates the successes of its high achieving women on International Women’s Day. Each of Pearce IP’s CEO, and heads of litigation and pro...
Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021. Under the settlement Alvotech will receive non-exclusive rights to market AVT02 (high-concentration, citrate-free biosimilar adalimumab) i...
MSD published interim results from its Ph III trial of Keytruda® (pembrolizumab) as an adjuvant treatment for patients with stage IIB and IIC melanoma. According to the announcement, the trial met its key secondary endpoint and showed an improvement in recurrent-free survi...
Shanghai Henlius Biotech announced that China’s NMPA has approved its biosimilar rituximab (汉利康®)), as the first biosimilar approved in combination with methotrexate for the treatment of adult patients with rheumatoid arthritis who have inadequate response to one or mor...
The Juvenile Diabetes Research Foundation (JDRF) announced that it has entered into a partnership with not-for-profit generic manufacturing company Civica to manufacture biosimilar insulins, including biosimilars to glargine (Lantus®), lispro (Humalog®), and aspart (Novolog...
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