Teva Tests Biosimilar Version of Roche's Rituxan
Teva Pharmaceutical Industries (Tikva, Israel) is developing a generic version of Roche's (Basel, Switzerland) blockbuster antibody drug Rituxan, in what may possibly be the first US generic version of a monoclonal antibody.
Teva Pharmaceutical Industries (Tikva, Israel) is developing a generic version of Roche's (Basel, Switzerland) blockbuster antibody drug Rituxan, in what may possibly be the first US generic version of a monoclonal antibody.
Teva is recruiting 60 patients in Germany and Hungary for a clinical trial comparing Roche's original product with its copy, known as TL011, in patients with rheumatoid arthritis. The study is due for completion in August 2011, according to a post on clinicaltrials.gov.
Teva's partner Lonza (Basel, Switzerland) was also involved in the trial and the drug is expected to be launched in the second half of 2014, assuming positive results in development and approval from regulators.
Rituxan, also known as MabThera, is marketed for treating non-Hodgkin's lymphoma, rheumatoid arthritis, and chronic lymphocytic leukemia. It is one of the older antibody drugs that generics companies are now eyeing as a major sales opportunity.
With the global market for branded biologic drugs worth more than $80 billion a year and roughly $50 billion of that business set to lose patent protection by 2015 or 2016, biosimilars like Rituxan are an enticing prospect.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
