Tagged as: biosimilar news

Henlius and Eurofarma Entered into a License Agreement for Henlius' 3 Products in Latin America

Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA (“Eurofarma”), a Brazilian multinational biopharmaceutical company, for the development, manufacturing and commercialization of three biosimilar products in 16 Latin American countries. The three products are HANLIKANG® (rituximab), HANQUYOU®…

Read More

Biosimilar Partnership News

Eris Lifesciences (“Eris”) announced its joint venture with Mumbai-based MJ Biopharm Pvt Ltd. (“MJ”),  Eris MJ Biopharm Ltd.,  focused on the marketing and distribution of insulins (including aspart, glargine and lispro), GLP1 agonists, and potentially other biopharma products in India.  Under the agreement, MJ will be responsible for the development,…

Read More

EMA Reports on Pilot Program on Tailored Scientific Advice for Biosimilar Development

On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were invited to solicit scientific advice from regulatory authorities. In the European Economic Area (EEA), biosimilar approval requires applicants to submit…

Read More

First Biosimilar Making “Paragraph IV” Certification under China’s New Patent Law: Bio-Thera Solutions Announced NMPA Acceptance of aBLA for Tocilizumab

On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab), which is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R).  Actemra® has been approved in the United States for the…

Read More

Coherus and Xbrane Announce Acceptance of Regulatory Submissions for Ranibizumab Biosimilars

On October 1, 2021, Coherus BioSciences announced that FDA has accepted for review Coherus’ BLA for CHS-201, a candidate biosimilar to Lucentis® (ranibizumab), which is indicated for neovascular age-related macular degeneration (nAMD) and several other ophthalmic conditions. The BLA was originally submitted by Coherus’ partner, BioeqAG.  On October 4, 2021,…

Read More

Ranibizumab Biosimilar Program Updates

This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD). On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the…

Read More

EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…

Read More

Biosimilar Market Updates

Shanghai Henlius biosimilar antibody developments On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products Administration (NMPA) for HLX14, a biosimililar to Amgen’s PROLIA (denosumab).  According to the press release, HLX14 is indicated for the treatment of…

Read More

Partnership Updates

COVID-19 Delays Proposed Combination of Mylan and Upjohn Mylan N.V. and Pfizer Inc. have announced that unprecedented circumstances surrounding the COVID-19 pandemic will delay the proposed integration of Mylan and Upjohn, a division of Pfizer.  As we previously reported, Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine…

Read More

12