Chairman of the 2019 Biosimilars Conference, Michel Mikhail, International Expert Regulatory Affairs, Global Expert of Biosimilars, invites biosimilar experts to attend the next Biosimilars Conference, taking place in London.
For FYB201, a biosimilar candidate for Lucentis (ranibizumab), Formycon and Bioeq IP AG successfully concluded a Type IV Pre-Submission Meeting in December 2018 with the US Food and Drug Administration (FDA).
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA's suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.
Coherus BioSciences, Inc. (“Coherus” or “the Company”, Nasdaq: CHRS), today reviewed corporate highlights and reported financial results for the quarter ended March 31, 2019.
Vizient, Inc. recently submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.
Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly announced today that IBI301, a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody being co-developed as a potential biosimilar to rituximab, which is sold under the brand name MabThera/Rituxan has met pre-defined primary endpoints in two randomized clinical trials comparing IBI301 to rituximab, namely: a phase III clinical trial (CIBI301A301) in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study (CIBI301A201) in patients with CD20-positive B-cell lymphoma. The details of these studies will be disclosed in future publications in scientific journals and conferences.
Biologic treatments have been approved and used in Canada for several decades, marking the beginning of an exciting time for the treatment of many diseases as these therapies truly changed the outcomes for many patients living with chronic and often fatal diseases.
Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announces recently that the company is launching its first biosimilar medicine in Germany. IDACIO is available in the following administration options: pre-filled syringe, pre-filled pen and the vial presentation.
Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that Amgen and Coherus have settled the trade secret action brought by Amgen against Coherus that was pending in the Superior Court of California County of Ventura.
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