Biocon Ltd. and Mylan N.V. recently announced that Health Canada has approved Mylan’s Ogivri (trastuzumab), a biosimilar to Herceptin (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
Recently, FDA released Draft Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations.
NeuClone Pharmaceuticals Ltd. (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced it will initiate the Phase I clinical trial of its Stelara® (ustekinumab) biosimilar in the second half of 2019.
Mylan N.V.(NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that final data from the HERITAGE study will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
AbbVie (NYSE: ABBV) announced that it has resolved U.S. HUMIRA (adalimumab) litigation with Boehringer Ingelheim (BI). Under the terms of the resolution, AbbVie will grant BI a non-exclusive license to its HUMIRA-related intellectual property in the United States.
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.
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